ID

41012

Description

Study ID: 103447 Clinical Study ID: NKV103447 Study Title:A study to evaluate the effect of casoptiant on cardiac conduction as assessed by 12-lead electrocardiogram as compared to placebo and moxifloxacin Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced

Keywords

Versions (2)
  1. 6/11/20 6/11/20 -
  2. 9/17/21 9/17/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 11, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Effect of casoptiant on cardiac conduction as compared to placebo and moxifloxacin 103447

English

Eligibility Question

1 forms  
  1. StudyEvent: ODM
    1. Eligibility Question
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Eligibility Question
Description

Eligibility Question

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Description

Did the subject meet all the entry criteria?

Data type

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. Healthy adults, between 18 and 55 years of age, inclusive.
Description

1. Healthy adults, between 18 and 55 years of age, inclusive.

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. Body weight >50 kg (110 lbs) and Body Mass Index (BMI) between 19 and 30 kg/m2.
Description

2. Body weight >50 kg (110 lbs) and Body Mass Index (BMI) between 19 and 30 kg/m2.

Data type

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C1305855
3. A female is eligible to enter and participate in this study if she is non-pregnant, non-lactating and if she is of: • non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including pre-menopausal females with documented (medical report verification) hysterectomy or double oophrectomy or post-menopausal females defined as being amenorrheic for greater than 1 year and having follicle stimulating hormone (FSH) levels consistent with menopause. • child-bearing potential, has a negative urine pregnancy test at screening, and agrees to comply with recognized non-hormonal or hormonal contraceptive methods during the treatment stage of the study and for a period of 12 weeks after stopping study drug. Recognized non-hormonal contraceptive methods include: abstinence, condoms, diaphragm with spermicide, and intrauterine device (IUD)
Description

3. A female is eligible to enter and participate in this study if she is non-pregnant, non-lactating, is of non-childbearing potential or child-bearing potential, has a negative urine pregnancy test at screening, and agrees to comply with recognized non-hormonal or hormonal contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
UMLS CUI [4]
C0279752
UMLS CUI [5]
C0020699
UMLS CUI [6]
C0278321
UMLS CUI [7,1]
C0232970
UMLS CUI [7,2]
C0002453
UMLS CUI [7,3]
C0733758
UMLS CUI [8]
C0427780
UMLS CUI [9]
C0700589
UMLS CUI [10]
C3843422
UMLS CUI [11]
C0677582
UMLS CUI [12,1]
C0042241
UMLS CUI [12,2]
C0037862
UMLS CUI [13]
C0021900
4. Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Description

4. Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
1. For female subjects, a positive urine β-hCG (human chorionic gonadotropin) test at screening indicating pregnancy; nursing women; and women of childbearing potential who are unwilling or unable to use an appropriate form of contraception prior to study medication administration and until completion of follow-up procedures.
Description

1. Urine pregnancy test; Positive | Pregnancy | Breast Feeding | Childbearing Potential | Contraceptive methods; Unable; Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0430056
UMLS CUI [1,2]
C1446409
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
UMLS CUI [4]
C3831118
UMLS CUI [5,1]
C0700589
UMLS CUI [5,2]
C1299582
UMLS CUI [5,3]
C0558080
2. Within the judgement of the Principal Investigator and the Sponsor, any clinically significant hematologic, endocrine, cardiovascular, hepatic, renal, gastrointestinal, and/or pulmonary disorder; any predisposing condition that might interfere with the absorption, distribution, metabolism, and/or excretion of drugs; any previous gastrointestinal surgery, except appendectomy, if performed more than 3 months prior to study screening; history of abnormal bleeding tendencies or thrombophlebitis; or any clinically relevant abnormality identified on physical examination, 12-lead ECG or clinical laboratories at screening.
Description

Hematological Disease | Endocrine System Diseases | Cardiovascular Diseases | Liver diseases | Kidney Diseases | Gastrointestinal Diseases | Bronchopulmonary disease | Condition; Interferes with; drug absorption; drug distribution (pharmacokinetics); drug metabolism; drug elimination | Gastrointestinal Surgical Procedure | Appendectomy | Bleeding tendency; Abnormal | Thrombophlebitis | Physical Examination; Abnormal result | 12 lead ECG; Abnormality | Laboratory; Abnormality

Data type

boolean

Alias
UMLS CUI [1]
C0018939
UMLS CUI [2]
C0014130
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0022658
UMLS CUI [6]
C0017178
UMLS CUI [7]
C1096000
UMLS CUI [8,1]
C0348080
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C0678745
UMLS CUI [8,4]
C0699903
UMLS CUI [8,5]
C0683140
UMLS CUI [8,6]
C0683141
UMLS CUI [9]
C0524722
UMLS CUI [10]
C0003611
UMLS CUI [11,1]
C1458140
UMLS CUI [11,2]
C0205161
UMLS CUI [12]
C0040046
UMLS CUI [13,1]
C0031809
UMLS CUI [13,2]
C0459424
UMLS CUI [14,1]
C0430456
UMLS CUI [14,2]
C1704258
UMLS CUI [15,1]
C0022877
UMLS CUI [15,2]
C1704258
3. Current or past history of significant renal disease including, but not limited to, any renal insufficiency, nephrolithiasis, microalbuminuria, glomerulonephropathy, glomerulonephritis, or interstitial nephritis.
Description

3. Current or past history of significant renal disease including, but not limited to, any renal insufficiency, nephrolithiasis, microalbuminuria, glomerulonephropathy, glomerulonephritis, or interstitial nephritis.

Data type

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C1565489
UMLS CUI [3]
C0392525
UMLS CUI [4]
C0730345
UMLS CUI [5]
C0268731
UMLS CUI [6]
C0017658
UMLS CUI [7]
C0027707
4. History of clinically significant cardiovascular disease including, but not limited to, angina, coronary artery bypass surgery or percutanenous transluminal coronary angioplasty (PTCA), conduction abnormality [including but not specific to left or right incomplete or complete bundle branch block, atrioventricular (AV) block (any degree), Wolf-Parkinson-White (WPW) syndrome, etc.], congestive heart failure, or cardiomyopathy.
Description

4. Cardiovascular Diseases | Angina Pectoris | Coronary Artery Bypass Surgery | Percutaneous Transluminal Coronary Angioplasty | Other conduction disorders | Incomplete right bundle branch block | Right bundle branch block | Incomplete left bundle branch block | Left Bundle-Branch Block | Atrioventricular Block | Wolff-Parkinson-White Syndrome | Congestive heart failure | Cardiomyopathies

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0002962
UMLS CUI [3]
C0010055
UMLS CUI [4]
C2936173
UMLS CUI [5]
C0340494
UMLS CUI [6]
C0262525
UMLS CUI [7]
C0085615
UMLS CUI [8]
C0281878
UMLS CUI [9]
C0023211
UMLS CUI [10]
C0004245
UMLS CUI [11]
C0043202
UMLS CUI [12]
C0018802
UMLS CUI [13]
C0878544
5. Clinically relevant abnormality on screening ECG, including • Ill-defined T wave • Non-sinus rhythm • Abnormal QRS axis deviation • Evidence of previous myocardial infarction (Q waves, S-T segment changes) • History/evidence of angina • Any conduction abnormality (including but not specific to left or right incomplete or complete bundle branch block, AV block (any degree), WPW syndrome) • Sinus Pauses > 2.5 seconds • Ventricular couplets, triplets or other noted arrhythmia, symptomatic or asymptomatic Heart rate: Males < 40 and > 100 bpm Females < 40 and > 100 bpm PR Interval: Males < 120 and > 200 msec Females < 120 and > 200 msec QRS duration: Males < 70 and >120 msec Females < 70 and > 120 msec QT interval: Males < 340 and > 450 msec Females < 340 and > 470 msec QTc interval (any correction factor): Males < 350 and > 450 msec Females < 350 and > 450 msec
Description

ECG abnormality | EKG: T wave abnormal | ecg non-sinus rhythm | QRS Axis (observable entity); Left axis deviation | QRS Axis (observable entity); Right axis deviation | History of myocardial infarction; Q wave | History of myocardial infarction; ECG Nonspecific ST-T change | Angina Pectoris | Other conduction disorders | Incomplete right bundle branch block | Incomplete left bundle branch block | Right bundle branch block | Left Bundle-Branch Block | Complete atrioventricular block | Wolff-Parkinson-White Syndrome | Sinus Arrest, Cardiac | Paired ventricular premature complexes | Ventricular triplet | ARRHYTHMIA SYMPTOMATIC | Cardiac Arrhythmia; C0231221 Asymptomatic | heart rate | Electrocardiogram: P-R interval | QRS complex duration (observable entity) | QT interval - finding | qtc interval

Data type

boolean

Alias
UMLS CUI [1]
C1832603
UMLS CUI [2]
C0438167
UMLS CUI [3]
C3649284
UMLS CUI [4,1]
C0429012
UMLS CUI [4,2]
C0232297
UMLS CUI [5,1]
C0429012
UMLS CUI [5,2]
C0232296
UMLS CUI [6,1]
C1275835
UMLS CUI [6,2]
C1305738
UMLS CUI [7,1]
C1275835
UMLS CUI [7,2]
C1112720
UMLS CUI [8]
C0002962
UMLS CUI [9]
C0340494
UMLS CUI [10]
C0262525
UMLS CUI [11]
C0281878
UMLS CUI [12]
C0085615
UMLS CUI [13]
C0023211
UMLS CUI [14]
C0151517
UMLS CUI [15]
C0043202
UMLS CUI [16]
C1955864
UMLS CUI [17]
C0429001
UMLS CUI [18]
C4087466
UMLS CUI [19]
C0741212
UMLS CUI [20,1]
C0003811
UMLS CUI [20,2]
C0231221
UMLS CUI [21]
C0018810
UMLS CUI [22]
C0429087
UMLS CUI [23]
C0429025
UMLS CUI [24]
C1287082
UMLS CUI [25]
C0489625
6. Hemoglobin < 11 g/dL at screening; history of hemoglobinopathy; or current or past history of methemoglobinemia or methemoglobin percentage above the reference range at screening.
Description

6. Hemoglobin < 11 g/dL at screening; history of hemoglobinopathy; or current or past history of methemoglobinemia or methemoglobin percentage above the reference range at screening.

Data type

boolean

Alias
UMLS CUI [1]
C0019046
UMLS CUI [2]
C0019045
UMLS CUI [3]
C0025637
UMLS CUI [4,1]
C0025635
UMLS CUI [4,2]
C2826705
UMLS CUI [5]
C0220908
7. Documented or suspected history of allergy to study drug or its components or other allergy, which, in the opinion of the Principal Investigator, contradicts their participation.
Description

7. Documented or suspected history of allergy to study drug or its components or other allergy, which, in the opinion of the Principal Investigator, contradicts their participation.

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0304229
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0304229
UMLS CUI [2,3]
C1705248
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0205394
UMLS CUI [4]
C2348568
8. History of hypersensitivity to moxifloxacin or any member of the quinolone class of antimicrobial agents.
Description

8. History of hypersensitivity to moxifloxacin or any member of the quinolone class of antimicrobial agents.

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0536495
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1882518
9. History of sensitivity to heparin or heparin-induced thrombocytopenia.
Description

9. History of sensitivity to heparin or heparin-induced thrombocytopenia.

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0019134
UMLS CUI [2]
C0272285
10. Use of prescription or non-prescription drugs (other than acetaminophen in doses < 2 grams/day and multivitamins), within seven days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
Description

10. Use of prescription or non-prescription drugs (other than acetaminophen in doses < 2 grams/day and multivitamins), within seven days or 5 half-lives (whichever is longer) prior to the first dose of study medication.

Data type

boolean

Alias
UMLS CUI [1]
C0013231
UMLS CUI [2]
C0304227
UMLS CUI [3,1]
C0000970
UMLS CUI [3,2]
C0205394
UMLS CUI [4]
C0178602
UMLS CUI [5]
C0301532
UMLS CUI [6]
C3173309
11. Use of dietary/herbal supplements including (but not limited to) St. John's wort, kava, ephedra (ma huang), gingko biloba, DHEA, yohimbe, saw palmetto, ginseng, red yeast rice, and excessive doses of vitamins (2-fold greater than the recommended daily allowance) within 14 days or 5 half-lives, whichever is longer, prior to Day -1 of Session 1 and until discharge from the study; or consumption of grapefruit-containing products within 14 days prior to the first dose of study medication.
Description

11. Dietary Supplements | Herbal Supplements | ST. JOHN'S WORT EXTRACT | Kava preparation | Ephedra | Ginkgo biloba | Dehydroepiandrosterone Sulfate | Yohimbe | Saw palmetto extract | Ginseng Preparation | red yeast rice | Vitamins; Dosage | Session; Before | Discharge; Before | Grapefruit (food) | Date treatment or therapy started

Data type

boolean

Alias
UMLS CUI [1]
C0242295
UMLS CUI [2]
C1504473
UMLS CUI [3]
C0813171
UMLS CUI [4]
C0939882
UMLS CUI [5]
C0950030
UMLS CUI [6]
C0330206
UMLS CUI [7]
C0057277
UMLS CUI [8]
C1123032
UMLS CUI [9]
C0771607
UMLS CUI [10]
C1119918
UMLS CUI [11]
C0763533
UMLS CUI [12,1]
C0042890
UMLS CUI [12,2]
C0178602
UMLS CUI [13,1]
C1883017
UMLS CUI [13,2]
C0332152
UMLS CUI [14,1]
C0030685
UMLS CUI [14,2]
C0332152
UMLS CUI [15]
C0995150
UMLS CUI [16]
C3173309
12. Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
Description

12. Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0332185
13. History of smoking or use of nicotine containing products for 3 months prior to study participation.
Description

13. History of smoking or use of nicotine containing products for 3 months prior to study participation.

Data type

boolean

Alias
UMLS CUI [1]
C1519384
UMLS CUI [2,1]
C1514468
UMLS CUI [2,2]
C0332256
UMLS CUI [2,3]
C0028040
14. History of illicit drug abuse within 6 months of the study.
Description

14. History of illicit drug abuse within 6 months of the study.

Data type

boolean

Alias
UMLS CUI [1]
C0743253
15. History of regular alcohol consumption exceeding 7 drinks/week for women or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
Description

15. History of regular alcohol consumption exceeding 7 drinks/week for women or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.

Data type

boolean

Alias
UMLS CUI [1]
C0001948
UMLS CUI [2]
C0560579
UMLS CUI [3]
C0043188
UMLS CUI [4]
C0559430
UMLS CUI [5]
C0559433
UMLS CUI [6]
C0220908
16. Unwillingness to adhere to the study Lifestyle Guidelines as described in Protocol Section 7.
Description

16. Unwillingness to adhere to the study Lifestyle Guidelines as described in Protocol Section 7.

Data type

boolean

Alias
UMLS CUI [1]
C0525058
17. Positive urine drug screen (UDS) at screening and pre-dose at each study session.
Description

17. Positive urine drug screen (UDS) at screening and pre-dose at each study session.

Data type

boolean

Alias
UMLS CUI [1]
C0743300
UMLS CUI [2]
C0220908
UMLS CUI [3]
C0439565
18. Positive for Human Immunodeficiency Virus (HIV) antibody, hepatitis B virus surface antigen or hepatitis C virus antibody at screening.
Description

18. Positive for Human Immunodeficiency Virus (HIV) antibody, hepatitis B virus surface antigen or hepatitis C virus antibody at screening.

Data type

boolean

Alias
UMLS CUI [1]
C0019683
UMLS CUI [2]
C0019168
UMLS CUI [3]
C0201487
UMLS CUI [4]
C0220908
19. Donation of blood in excess of 500 mL within 56 days prior to dosing.
Description

19. Donation of blood in excess of 500 mL within 56 days prior to dosing.

Data type

boolean

Alias
UMLS CUI [1]
C0005794
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Similar models

Eligibility Question

1 forms
  1. StudyEvent: ODM
    1. Eligibility Question
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Eligibility Question
C1516637 (UMLS CUI-1)
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
1. Healthy adults, between 18 and 55 years of age, inclusive.
Item
1. Healthy adults, between 18 and 55 years of age, inclusive.
boolean
C0001779 (UMLS CUI [1])
2. Body weight >50 kg (110 lbs) and Body Mass Index (BMI) between 19 and 30 kg/m2.
Item
2. Body weight >50 kg (110 lbs) and Body Mass Index (BMI) between 19 and 30 kg/m2.
boolean
C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
3. A female is eligible to enter and participate in this study if she is non-pregnant, non-lactating, is of non-childbearing potential or child-bearing potential, has a negative urine pregnancy test at screening, and agrees to comply with recognized non-hormonal or hormonal contraceptive methods
Item
3. A female is eligible to enter and participate in this study if she is non-pregnant, non-lactating and if she is of: • non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including pre-menopausal females with documented (medical report verification) hysterectomy or double oophrectomy or post-menopausal females defined as being amenorrheic for greater than 1 year and having follicle stimulating hormone (FSH) levels consistent with menopause. • child-bearing potential, has a negative urine pregnancy test at screening, and agrees to comply with recognized non-hormonal or hormonal contraceptive methods during the treatment stage of the study and for a period of 12 weeks after stopping study drug. Recognized non-hormonal contraceptive methods include: abstinence, condoms, diaphragm with spermicide, and intrauterine device (IUD)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
C0279752 (UMLS CUI [4])
C0020699 (UMLS CUI [5])
C0278321 (UMLS CUI [6])
C0232970 (UMLS CUI [7,1])
C0002453 (UMLS CUI [7,2])
C0733758 (UMLS CUI [7,3])
C0427780 (UMLS CUI [8])
C0700589 (UMLS CUI [9])
C3843422 (UMLS CUI [10])
C0677582 (UMLS CUI [11])
C0042241 (UMLS CUI [12,1])
C0037862 (UMLS CUI [12,2])
C0021900 (UMLS CUI [13])
4. Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Item
4. Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
1. Urine pregnancy test; Positive | Pregnancy | Breast Feeding | Childbearing Potential | Contraceptive methods; Unable; Unwilling
Item
1. For female subjects, a positive urine β-hCG (human chorionic gonadotropin) test at screening indicating pregnancy; nursing women; and women of childbearing potential who are unwilling or unable to use an appropriate form of contraception prior to study medication administration and until completion of follow-up procedures.
boolean
C0430056 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C3831118 (UMLS CUI [4])
C0700589 (UMLS CUI [5,1])
C1299582 (UMLS CUI [5,2])
C0558080 (UMLS CUI [5,3])
Hematological Disease | Endocrine System Diseases | Cardiovascular Diseases | Liver diseases | Kidney Diseases | Gastrointestinal Diseases | Bronchopulmonary disease | Condition; Interferes with; drug absorption; drug distribution (pharmacokinetics); drug metabolism; drug elimination | Gastrointestinal Surgical Procedure | Appendectomy | Bleeding tendency; Abnormal | Thrombophlebitis | Physical Examination; Abnormal result | 12 lead ECG; Abnormality | Laboratory; Abnormality
Item
2. Within the judgement of the Principal Investigator and the Sponsor, any clinically significant hematologic, endocrine, cardiovascular, hepatic, renal, gastrointestinal, and/or pulmonary disorder; any predisposing condition that might interfere with the absorption, distribution, metabolism, and/or excretion of drugs; any previous gastrointestinal surgery, except appendectomy, if performed more than 3 months prior to study screening; history of abnormal bleeding tendencies or thrombophlebitis; or any clinically relevant abnormality identified on physical examination, 12-lead ECG or clinical laboratories at screening.
boolean
C0018939 (UMLS CUI [1])
C0014130 (UMLS CUI [2])
C0007222 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
C0017178 (UMLS CUI [6])
C1096000 (UMLS CUI [7])
C0348080 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C0678745 (UMLS CUI [8,3])
C0699903 (UMLS CUI [8,4])
C0683140 (UMLS CUI [8,5])
C0683141 (UMLS CUI [8,6])
C0524722 (UMLS CUI [9])
C0003611 (UMLS CUI [10])
C1458140 (UMLS CUI [11,1])
C0205161 (UMLS CUI [11,2])
C0040046 (UMLS CUI [12])
C0031809 (UMLS CUI [13,1])
C0459424 (UMLS CUI [13,2])
C0430456 (UMLS CUI [14,1])
C1704258 (UMLS CUI [14,2])
C0022877 (UMLS CUI [15,1])
C1704258 (UMLS CUI [15,2])
3. Current or past history of significant renal disease including, but not limited to, any renal insufficiency, nephrolithiasis, microalbuminuria, glomerulonephropathy, glomerulonephritis, or interstitial nephritis.
Item
3. Current or past history of significant renal disease including, but not limited to, any renal insufficiency, nephrolithiasis, microalbuminuria, glomerulonephropathy, glomerulonephritis, or interstitial nephritis.
boolean
C0022658 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
C0392525 (UMLS CUI [3])
C0730345 (UMLS CUI [4])
C0268731 (UMLS CUI [5])
C0017658 (UMLS CUI [6])
C0027707 (UMLS CUI [7])
4. Cardiovascular Diseases | Angina Pectoris | Coronary Artery Bypass Surgery | Percutaneous Transluminal Coronary Angioplasty | Other conduction disorders | Incomplete right bundle branch block | Right bundle branch block | Incomplete left bundle branch block | Left Bundle-Branch Block | Atrioventricular Block | Wolff-Parkinson-White Syndrome | Congestive heart failure | Cardiomyopathies
Item
4. History of clinically significant cardiovascular disease including, but not limited to, angina, coronary artery bypass surgery or percutanenous transluminal coronary angioplasty (PTCA), conduction abnormality [including but not specific to left or right incomplete or complete bundle branch block, atrioventricular (AV) block (any degree), Wolf-Parkinson-White (WPW) syndrome, etc.], congestive heart failure, or cardiomyopathy.
boolean
C0007222 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
C2936173 (UMLS CUI [4])
C0340494 (UMLS CUI [5])
C0262525 (UMLS CUI [6])
C0085615 (UMLS CUI [7])
C0281878 (UMLS CUI [8])
C0023211 (UMLS CUI [9])
C0004245 (UMLS CUI [10])
C0043202 (UMLS CUI [11])
C0018802 (UMLS CUI [12])
C0878544 (UMLS CUI [13])
ECG abnormality | EKG: T wave abnormal | ecg non-sinus rhythm | QRS Axis (observable entity); Left axis deviation | QRS Axis (observable entity); Right axis deviation | History of myocardial infarction; Q wave | History of myocardial infarction; ECG Nonspecific ST-T change | Angina Pectoris | Other conduction disorders | Incomplete right bundle branch block | Incomplete left bundle branch block | Right bundle branch block | Left Bundle-Branch Block | Complete atrioventricular block | Wolff-Parkinson-White Syndrome | Sinus Arrest, Cardiac | Paired ventricular premature complexes | Ventricular triplet | ARRHYTHMIA SYMPTOMATIC | Cardiac Arrhythmia; C0231221 Asymptomatic | heart rate | Electrocardiogram: P-R interval | QRS complex duration (observable entity) | QT interval - finding | qtc interval
Item
5. Clinically relevant abnormality on screening ECG, including • Ill-defined T wave • Non-sinus rhythm • Abnormal QRS axis deviation • Evidence of previous myocardial infarction (Q waves, S-T segment changes) • History/evidence of angina • Any conduction abnormality (including but not specific to left or right incomplete or complete bundle branch block, AV block (any degree), WPW syndrome) • Sinus Pauses > 2.5 seconds • Ventricular couplets, triplets or other noted arrhythmia, symptomatic or asymptomatic Heart rate: Males < 40 and > 100 bpm Females < 40 and > 100 bpm PR Interval: Males < 120 and > 200 msec Females < 120 and > 200 msec QRS duration: Males < 70 and >120 msec Females < 70 and > 120 msec QT interval: Males < 340 and > 450 msec Females < 340 and > 470 msec QTc interval (any correction factor): Males < 350 and > 450 msec Females < 350 and > 450 msec
boolean
C1832603 (UMLS CUI [1])
C0438167 (UMLS CUI [2])
C3649284 (UMLS CUI [3])
C0429012 (UMLS CUI [4,1])
C0232297 (UMLS CUI [4,2])
C0429012 (UMLS CUI [5,1])
C0232296 (UMLS CUI [5,2])
C1275835 (UMLS CUI [6,1])
C1305738 (UMLS CUI [6,2])
C1275835 (UMLS CUI [7,1])
C1112720 (UMLS CUI [7,2])
C0002962 (UMLS CUI [8])
C0340494 (UMLS CUI [9])
C0262525 (UMLS CUI [10])
C0281878 (UMLS CUI [11])
C0085615 (UMLS CUI [12])
C0023211 (UMLS CUI [13])
C0151517 (UMLS CUI [14])
C0043202 (UMLS CUI [15])
C1955864 (UMLS CUI [16])
C0429001 (UMLS CUI [17])
C4087466 (UMLS CUI [18])
C0741212 (UMLS CUI [19])
C0003811 (UMLS CUI [20,1])
C0231221 (UMLS CUI [20,2])
C0018810 (UMLS CUI [21])
C0429087 (UMLS CUI [22])
C0429025 (UMLS CUI [23])
C1287082 (UMLS CUI [24])
C0489625 (UMLS CUI [25])
6. Hemoglobin < 11 g/dL at screening; history of hemoglobinopathy; or current or past history of methemoglobinemia or methemoglobin percentage above the reference range at screening.
Item
6. Hemoglobin < 11 g/dL at screening; history of hemoglobinopathy; or current or past history of methemoglobinemia or methemoglobin percentage above the reference range at screening.
boolean
C0019046 (UMLS CUI [1])
C0019045 (UMLS CUI [2])
C0025637 (UMLS CUI [3])
C0025635 (UMLS CUI [4,1])
C2826705 (UMLS CUI [4,2])
C0220908 (UMLS CUI [5])
7. Documented or suspected history of allergy to study drug or its components or other allergy, which, in the opinion of the Principal Investigator, contradicts their participation.
Item
7. Documented or suspected history of allergy to study drug or its components or other allergy, which, in the opinion of the Principal Investigator, contradicts their participation.
boolean
C0020517 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C2348568 (UMLS CUI [4])
8. History of hypersensitivity to moxifloxacin or any member of the quinolone class of antimicrobial agents.
Item
8. History of hypersensitivity to moxifloxacin or any member of the quinolone class of antimicrobial agents.
boolean
C0020517 (UMLS CUI [1,1])
C0536495 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1882518 (UMLS CUI [2,2])
9. History of sensitivity to heparin or heparin-induced thrombocytopenia.
Item
9. History of sensitivity to heparin or heparin-induced thrombocytopenia.
boolean
C0020517 (UMLS CUI [1,1])
C0019134 (UMLS CUI [1,2])
C0272285 (UMLS CUI [2])
10. Use of prescription or non-prescription drugs (other than acetaminophen in doses < 2 grams/day and multivitamins), within seven days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
Item
10. Use of prescription or non-prescription drugs (other than acetaminophen in doses < 2 grams/day and multivitamins), within seven days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
boolean
C0013231 (UMLS CUI [1])
C0304227 (UMLS CUI [2])
C0000970 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C0178602 (UMLS CUI [4])
C0301532 (UMLS CUI [5])
C3173309 (UMLS CUI [6])
11. Dietary Supplements | Herbal Supplements | ST. JOHN'S WORT EXTRACT | Kava preparation | Ephedra | Ginkgo biloba | Dehydroepiandrosterone Sulfate | Yohimbe | Saw palmetto extract | Ginseng Preparation | red yeast rice | Vitamins; Dosage | Session; Before | Discharge; Before | Grapefruit (food) | Date treatment or therapy started
Item
11. Use of dietary/herbal supplements including (but not limited to) St. John's wort, kava, ephedra (ma huang), gingko biloba, DHEA, yohimbe, saw palmetto, ginseng, red yeast rice, and excessive doses of vitamins (2-fold greater than the recommended daily allowance) within 14 days or 5 half-lives, whichever is longer, prior to Day -1 of Session 1 and until discharge from the study; or consumption of grapefruit-containing products within 14 days prior to the first dose of study medication.
boolean
C0242295 (UMLS CUI [1])
C1504473 (UMLS CUI [2])
C0813171 (UMLS CUI [3])
C0939882 (UMLS CUI [4])
C0950030 (UMLS CUI [5])
C0330206 (UMLS CUI [6])
C0057277 (UMLS CUI [7])
C1123032 (UMLS CUI [8])
C0771607 (UMLS CUI [9])
C1119918 (UMLS CUI [10])
C0763533 (UMLS CUI [11])
C0042890 (UMLS CUI [12,1])
C0178602 (UMLS CUI [12,2])
C1883017 (UMLS CUI [13,1])
C0332152 (UMLS CUI [13,2])
C0030685 (UMLS CUI [14,1])
C0332152 (UMLS CUI [14,2])
C0995150 (UMLS CUI [15])
C3173309 (UMLS CUI [16])
12. Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
Item
12. Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
boolean
C0304229 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
13. History of smoking or use of nicotine containing products for 3 months prior to study participation.
Item
13. History of smoking or use of nicotine containing products for 3 months prior to study participation.
boolean
C1519384 (UMLS CUI [1])
C1514468 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C0028040 (UMLS CUI [2,3])
14. History of illicit drug abuse within 6 months of the study.
Item
14. History of illicit drug abuse within 6 months of the study.
boolean
C0743253 (UMLS CUI [1])
15. History of regular alcohol consumption exceeding 7 drinks/week for women or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
Item
15. History of regular alcohol consumption exceeding 7 drinks/week for women or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
boolean
C0001948 (UMLS CUI [1])
C0560579 (UMLS CUI [2])
C0043188 (UMLS CUI [3])
C0559430 (UMLS CUI [4])
C0559433 (UMLS CUI [5])
C0220908 (UMLS CUI [6])
16. Unwillingness to adhere to the study Lifestyle Guidelines as described in Protocol Section 7.
Item
16. Unwillingness to adhere to the study Lifestyle Guidelines as described in Protocol Section 7.
boolean
C0525058 (UMLS CUI [1])
17. Positive urine drug screen (UDS) at screening and pre-dose at each study session.
Item
17. Positive urine drug screen (UDS) at screening and pre-dose at each study session.
boolean
C0743300 (UMLS CUI [1])
C0220908 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
18. Positive for Human Immunodeficiency Virus (HIV) antibody, hepatitis B virus surface antigen or hepatitis C virus antibody at screening.
Item
18. Positive for Human Immunodeficiency Virus (HIV) antibody, hepatitis B virus surface antigen or hepatitis C virus antibody at screening.
boolean
C0019683 (UMLS CUI [1])
C0019168 (UMLS CUI [2])
C0201487 (UMLS CUI [3])
C0220908 (UMLS CUI [4])
19. Donation of blood in excess of 500 mL within 56 days prior to dosing.
Item
19. Donation of blood in excess of 500 mL within 56 days prior to dosing.
boolean
C0005794 (UMLS CUI [1])
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