ID

40501

Beschreibung

A Phase 1 Study to Assess the Safety,Tolerability, and Pharmacokinetics of GS-6615 in Healthy Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT01847391

Link

https://clinicaltrials.gov/show/NCT01847391

Stichworte

Versionen (1)
  1. 27.04.20 27.04.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

27. April 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Ischemic Heart Disease NCT01847391

Englisch

Eligibility Ischemic Heart Disease NCT01847391

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
weight of at least 50 kg with body mass index (bmi) between 18 and 30 kg/m2
Beschreibung

Body Weight | Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C1305855
female subjects must be of non-childbearing potential as defined per the protocol
Beschreibung

Gender | Childbearing Potential Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0332197
male subjects with female partners of childbearing potential must be using protocol acceptable methods of contraception
Beschreibung

Gender Partner Childbearing Potential | Gender Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0682323
UMLS CUI [1,3]
C3831118
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
willing and able to comply with the requirements of the protocol and directions
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
willing to avoid consumption of grapefruit, grapefruit juice and seville oranges
Beschreibung

Avoidance Consumption Grapefruit | Avoidance Consumption GRAPEFRUIT JUICE | Avoidance Consumption Seville orange Fruit

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0870186
UMLS CUI [1,2]
C0009830
UMLS CUI [1,3]
C0995150
UMLS CUI [2,1]
C0870186
UMLS CUI [2,2]
C0009830
UMLS CUI [2,3]
C0452456
UMLS CUI [3,1]
C0870186
UMLS CUI [3,2]
C0009830
UMLS CUI [3,3]
C0330922
UMLS CUI [3,4]
C0016767
willing to avoid consumption of nicotine (including nicotine gum) and alcoholic beverages
Beschreibung

Avoidance Consumption Nicotine | Avoidance Consumption Nicotine Chewing Gum | Avoidance Consumption Alcoholic Beverages

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0870186
UMLS CUI [1,2]
C0009830
UMLS CUI [1,3]
C0028040
UMLS CUI [2,1]
C0870186
UMLS CUI [2,2]
C0009830
UMLS CUI [2,3]
C0599654
UMLS CUI [3,1]
C0870186
UMLS CUI [3,2]
C0009830
UMLS CUI [3,3]
C0001967
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
ongoing or history of any medical or surgical condition that, in the judgment of the investigator, might jeopardize the subject's safety or interfere with the study objectives
Beschreibung

Medical condition At risk Patient safety | Operative Surgical Procedure At risk Patient safety | Medical condition Interferes with Study Protocol | Operative Surgical Procedure Interferes with Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C1113679
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348563
UMLS CUI [4,1]
C0543467
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C2348563
history of meningitis or encephalitis, seizures, migraines, tremors, myoclonic jerks, sleep disorder, anxiety, syncope, head injuries or a family history of seizures
Beschreibung

Meningitis | Encephalitis | Seizures | Migraine | Tremor | Myoclonus | Sleep Disorders | Anxiety | Syncope | Craniocerebral Trauma | Family history Seizures

Datentyp

boolean

Alias
UMLS CUI [1]
C0025289
UMLS CUI [2]
C0014038
UMLS CUI [3]
C0036572
UMLS CUI [4]
C0149931
UMLS CUI [5]
C0040822
UMLS CUI [6]
C0027066
UMLS CUI [7]
C0851578
UMLS CUI [8]
C0003467
UMLS CUI [9]
C0039070
UMLS CUI [10]
C0018674
UMLS CUI [11,1]
C0241889
UMLS CUI [11,2]
C0036572
any abnormal ecg findings, abnormal laboratory value, or physical examination findings at screening judged to be clinically significant
Beschreibung

ECG abnormal | Laboratory test result abnormal | Physical examination abnormal

Datentyp

boolean

Alias
UMLS CUI [1]
C0522055
UMLS CUI [2]
C0438215
UMLS CUI [3]
C0747585
any abnormal neurological examination findings at screening that is judged as clinically significant
Beschreibung

Neurological examination abnormal

Datentyp

boolean

Alias
UMLS CUI [1]
C1112537
hemoglobin < 12 g/dl
Beschreibung

Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0518015
serology test positive for hiv, or hepatitis b or c
Beschreibung

HIV Seropositivity | Serology positive Hepatitis B | Serology positive Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2,1]
C0242089
UMLS CUI [2,2]
C0019163
UMLS CUI [3,1]
C0242089
UMLS CUI [3,2]
C0019196
positive urine drug test (including cotinine or ethanol)
Beschreibung

Urine drug screen positive | Urine cotinine test positive | Urine drug screen ethanol Positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0743300
UMLS CUI [2]
C1699505
UMLS CUI [3,1]
C2188602
UMLS CUI [3,2]
C1514241
use of systemic prescription medications or over the counter (otc) medication, including multivitamins, and dietary and herbal supplement
Beschreibung

Pharmaceutical Preparations Systemic | Non-Prescription Drugs Systemic | Multivitamin preparation | Dietary Supplements | Herbal Supplements

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205373
UMLS CUI [2,1]
C0013231
UMLS CUI [2,2]
C0205373
UMLS CUI [3]
C0301532
UMLS CUI [4]
C0242295
UMLS CUI [5]
C1504473
use of any experimental or investigational drug or device within 30 days
Beschreibung

Investigational New Drugs | Investigational Medical Device

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2346570
female subjects who are of childbearing potential, pregnant or lactating
Beschreibung

Childbearing Potential | Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
donation or loss of blood within 8 weeks and/or donation of plasma within 7 days
Beschreibung

Blood Donation | Blood Loss | Plasma Charitable contribution

Datentyp

boolean

Alias
UMLS CUI [1]
C0005794
UMLS CUI [2]
C3163616
UMLS CUI [3,1]
C0032105
UMLS CUI [3,2]
C0680854
history of drug or alcohol abuse
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
psychosocial or addictive disorders
Beschreibung

Psychosocial problem | Addictive Behavior

Datentyp

boolean

Alias
UMLS CUI [1]
C0740697
UMLS CUI [2]
C0085281
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Ähnliche Modelle

Eligibility Ischemic Heart Disease NCT01847391

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Body Weight | Body mass index
Item
weight of at least 50 kg with body mass index (bmi) between 18 and 30 kg/m2
boolean
C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Gender | Childbearing Potential Absent
Item
female subjects must be of non-childbearing potential as defined per the protocol
boolean
C0079399 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Gender Partner Childbearing Potential | Gender Contraceptive methods
Item
male subjects with female partners of childbearing potential must be using protocol acceptable methods of contraception
boolean
C0079399 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C3831118 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Protocol Compliance
Item
willing and able to comply with the requirements of the protocol and directions
boolean
C0525058 (UMLS CUI [1])
Avoidance Consumption Grapefruit | Avoidance Consumption GRAPEFRUIT JUICE | Avoidance Consumption Seville orange Fruit
Item
willing to avoid consumption of grapefruit, grapefruit juice and seville oranges
boolean
C0870186 (UMLS CUI [1,1])
C0009830 (UMLS CUI [1,2])
C0995150 (UMLS CUI [1,3])
C0870186 (UMLS CUI [2,1])
C0009830 (UMLS CUI [2,2])
C0452456 (UMLS CUI [2,3])
C0870186 (UMLS CUI [3,1])
C0009830 (UMLS CUI [3,2])
C0330922 (UMLS CUI [3,3])
C0016767 (UMLS CUI [3,4])
Avoidance Consumption Nicotine | Avoidance Consumption Nicotine Chewing Gum | Avoidance Consumption Alcoholic Beverages
Item
willing to avoid consumption of nicotine (including nicotine gum) and alcoholic beverages
boolean
C0870186 (UMLS CUI [1,1])
C0009830 (UMLS CUI [1,2])
C0028040 (UMLS CUI [1,3])
C0870186 (UMLS CUI [2,1])
C0009830 (UMLS CUI [2,2])
C0599654 (UMLS CUI [2,3])
C0870186 (UMLS CUI [3,1])
C0009830 (UMLS CUI [3,2])
C0001967 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Medical condition At risk Patient safety | Operative Surgical Procedure At risk Patient safety | Medical condition Interferes with Study Protocol | Operative Surgical Procedure Interferes with Study Protocol
Item
ongoing or history of any medical or surgical condition that, in the judgment of the investigator, might jeopardize the subject's safety or interfere with the study objectives
boolean
C3843040 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0543467 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348563 (UMLS CUI [3,3])
C0543467 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2348563 (UMLS CUI [4,3])
Meningitis | Encephalitis | Seizures | Migraine | Tremor | Myoclonus | Sleep Disorders | Anxiety | Syncope | Craniocerebral Trauma | Family history Seizures
Item
history of meningitis or encephalitis, seizures, migraines, tremors, myoclonic jerks, sleep disorder, anxiety, syncope, head injuries or a family history of seizures
boolean
C0025289 (UMLS CUI [1])
C0014038 (UMLS CUI [2])
C0036572 (UMLS CUI [3])
C0149931 (UMLS CUI [4])
C0040822 (UMLS CUI [5])
C0027066 (UMLS CUI [6])
C0851578 (UMLS CUI [7])
C0003467 (UMLS CUI [8])
C0039070 (UMLS CUI [9])
C0018674 (UMLS CUI [10])
C0241889 (UMLS CUI [11,1])
C0036572 (UMLS CUI [11,2])
ECG abnormal | Laboratory test result abnormal | Physical examination abnormal
Item
any abnormal ecg findings, abnormal laboratory value, or physical examination findings at screening judged to be clinically significant
boolean
C0522055 (UMLS CUI [1])
C0438215 (UMLS CUI [2])
C0747585 (UMLS CUI [3])
Neurological examination abnormal
Item
any abnormal neurological examination findings at screening that is judged as clinically significant
boolean
C1112537 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin < 12 g/dl
boolean
C0518015 (UMLS CUI [1])
HIV Seropositivity | Serology positive Hepatitis B | Serology positive Hepatitis C
Item
serology test positive for hiv, or hepatitis b or c
boolean
C0019699 (UMLS CUI [1])
C0242089 (UMLS CUI [2,1])
C0019163 (UMLS CUI [2,2])
C0242089 (UMLS CUI [3,1])
C0019196 (UMLS CUI [3,2])
Urine drug screen positive | Urine cotinine test positive | Urine drug screen ethanol Positive
Item
positive urine drug test (including cotinine or ethanol)
boolean
C0743300 (UMLS CUI [1])
C1699505 (UMLS CUI [2])
C2188602 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
Pharmaceutical Preparations Systemic | Non-Prescription Drugs Systemic | Multivitamin preparation | Dietary Supplements | Herbal Supplements
Item
use of systemic prescription medications or over the counter (otc) medication, including multivitamins, and dietary and herbal supplement
boolean
C0013227 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0013231 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0301532 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
C1504473 (UMLS CUI [5])
Investigational New Drugs | Investigational Medical Device
Item
use of any experimental or investigational drug or device within 30 days
boolean
C0013230 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
Childbearing Potential | Pregnancy | Breast Feeding
Item
female subjects who are of childbearing potential, pregnant or lactating
boolean
C3831118 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Blood Donation | Blood Loss | Plasma Charitable contribution
Item
donation or loss of blood within 8 weeks and/or donation of plasma within 7 days
boolean
C0005794 (UMLS CUI [1])
C3163616 (UMLS CUI [2])
C0032105 (UMLS CUI [3,1])
C0680854 (UMLS CUI [3,2])
Substance Use Disorders
Item
history of drug or alcohol abuse
boolean
C0038586 (UMLS CUI [1])
Psychosocial problem | Addictive Behavior
Item
psychosocial or addictive disorders
boolean
C0740697 (UMLS CUI [1])
C0085281 (UMLS CUI [2])
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