ID

31355

Description

Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 9-1067; ODM derived from: https://clinicaltrials.gov/show/NCT02071810

Link

https://clinicaltrials.gov/show/NCT02071810

Keywords

Versions (2)
  1. 8/18/18 8/18/18 -
  2. 8/18/18 8/18/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 18, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Parkinson's Disease (PD) NCT02071810

English

Eligibility Parkinson's Disease (PD) NCT02071810

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. a signed and dated informed consent form before any study-specific screening procedure is performed.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. aged between 18 and 45 years, inclusive.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and digital 12-lead electrocardiogram (ecg).
Description

Healthy Medical History | Healthy Physical Examination | Healthy Laboratory Results | Healthy Vital signs | Healthy 12 lead ECG

Data type

boolean

Alias
UMLS CUI [1,1]
C3898900
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C3898900
UMLS CUI [2,2]
C0031809
UMLS CUI [3,1]
C3898900
UMLS CUI [3,2]
C1254595
UMLS CUI [4,1]
C3898900
UMLS CUI [4,2]
C0150404
UMLS CUI [5,1]
C3898900
UMLS CUI [5,2]
C0430456
4. nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. must be able to abstain from smoking during the inpatient stay.
Description

Non-smoker | Tobacco use Number of cigarettes per day | Avoidance Tobacco use During Inpatient stay

Data type

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2,1]
C0543414
UMLS CUI [2,2]
C3694146
UMLS CUI [3,1]
C0870186
UMLS CUI [3,2]
C0543414
UMLS CUI [3,3]
C0347984
UMLS CUI [3,4]
C0420512
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. any significant cardiovascular (e.g. hypertension), hepatic, renal, respiratory (e.g. childhood asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia), immunologic, dermatological, haematological, neurologic, or psychiatric disease.
Description

Cardiovascular Diseases | Hypertensive disease | Liver diseases | Kidney Diseases | Respiration Disorders | Childhood asthma | Gastrointestinal Diseases | Endocrine System Diseases | Diabetes Mellitus | Dyslipidemia | Immune System Diseases | Dermatologic disorders | Hematological Disease | Nervous system disorder | Mental disorders

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0020538
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0035204
UMLS CUI [6]
C0264408
UMLS CUI [7]
C0017178
UMLS CUI [8]
C0014130
UMLS CUI [9]
C0011849
UMLS CUI [10]
C0242339
UMLS CUI [11]
C0021053
UMLS CUI [12]
C0037274
UMLS CUI [13]
C0018939
UMLS CUI [14]
C0027765
UMLS CUI [15]
C0004936
2. acute disease state (e.g., nausea, vomiting, fever, diarrhoea) within 7 days before study day 1.
Description

Nausea | Vomiting | Fever | Diarrhea

Data type

boolean

Alias
UMLS CUI [1]
C0027497
UMLS CUI [2]
C0042963
UMLS CUI [3]
C0015967
UMLS CUI [4]
C0011991
3. history of drug abuse within 1 year before study day 1.
Description

Drug abuse

Data type

boolean

Alias
UMLS CUI [1]
C0013146
4. history of alcoholism within 1 year before day 1. consumption of more than 50 g of ethanol per day (12.5 cl glass of 10° [10%] wine = 12 g; 4 cl of aperitif, 42° [42%] whiskey = 17 g; 25 cl glass of 3° [3%] beer = 7.5 g; 25 cl glass of 6° [6%] beer = 15 g
Description

Alcoholic Intoxication, Chronic | Consumption Ethanol g/day | Consumption Wine g/day | Consumption Aperitif wine cl per day | Consumption Whisky g/day | Consumption Beer g/day

Data type

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0001962
UMLS CUI [2,3]
C0439417
UMLS CUI [3,1]
C0001948
UMLS CUI [3,2]
C0043188
UMLS CUI [3,3]
C0439417
UMLS CUI [4,1]
C0001948
UMLS CUI [4,2]
C0678400
UMLS CUI [4,3]
C0475212
UMLS CUI [4,4]
C0439505
UMLS CUI [5,1]
C0001948
UMLS CUI [5,2]
C0475610
UMLS CUI [5,3]
C0439417
UMLS CUI [6,1]
C0001948
UMLS CUI [6,2]
C0004922
UMLS CUI [6,3]
C0439417
5. have previously received bia 9-1067.
Description

BIA 9-1067

Data type

boolean

Alias
UMLS CUI [1]
C2933913
6. positive serologic findings for human immunodeficiency virus (hiv) antibodies, hepatitis b surface antigen (hbsag), and/or hepatitis c virus (hcv) antibodies.
Description

HIV antibody positive | Serology positive Hepatitis B Surface Antigens | Serology positive Hepatitis C Antibodies

Data type

boolean

Alias
UMLS CUI [1]
C0920548
UMLS CUI [2,1]
C0242089
UMLS CUI [2,2]
C0019168
UMLS CUI [3,1]
C0242089
UMLS CUI [3,2]
C0166049
7. positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, mdma [3,4-methylenedioxy-methamphetamine; ecstasy]).
Description

Urine drug screen positive | Amphetamines | Barbiturates | Benzodiazepines | Cannabinoids | Cocaine | Methadone | Opiates | Ecstasy - drug

Data type

boolean

Alias
UMLS CUI [1]
C0743300
UMLS CUI [2]
C0002667
UMLS CUI [3]
C0004745
UMLS CUI [4]
C0005064
UMLS CUI [5]
C0006864
UMLS CUI [6]
C0009170
UMLS CUI [7]
C0025605
UMLS CUI [8]
C0376196
UMLS CUI [9]
C0115471
8. history of any clinically important drug allergy.
Description

Drug Allergy

Data type

boolean

Alias
UMLS CUI [1]
C0013182
9. prohibited treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product (imp) administration.
Description

Investigational New Drugs Recently | Pharmaceutical Preparations Recently

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0332185
10. consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 24 before study day 1.
Description

Consumption of Caffeine containing substance Excessive | Coffee | Tea | Hot chocolate drink | Soda | Consumption of GRAPEFRUIT Excessive | Consumption of product containing Grapefruit | Consumption of Alcoholic Beverages Excessive

Data type

boolean

Alias
UMLS CUI [1,1]
C0009830
UMLS CUI [1,2]
C0565794
UMLS CUI [1,3]
C0442802
UMLS CUI [2]
C0009237
UMLS CUI [3]
C0039400
UMLS CUI [4]
C0452243
UMLS CUI [5]
C0683086
UMLS CUI [6,1]
C0009830
UMLS CUI [6,2]
C0452456
UMLS CUI [6,3]
C0442802
UMLS CUI [7,1]
C0009830
UMLS CUI [7,2]
C0681562
UMLS CUI [7,3]
C0332256
UMLS CUI [7,4]
C0995150
UMLS CUI [8,1]
C0009830
UMLS CUI [8,2]
C0001967
UMLS CUI [8,3]
C0442802
11. use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen [paracetamol], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before imp administration.
Description

Drugs, Non-Prescription | Herbal Supplements | Exception Acetaminophen occasional | Exception Aspirin occasional | Exception Vitamins occasional

Data type

boolean

Alias
UMLS CUI [1]
C0013231
UMLS CUI [2]
C1504473
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0000970
UMLS CUI [3,3]
C0521114
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0004057
UMLS CUI [4,3]
C0521114
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0042890
UMLS CUI [5,3]
C0521114
12. donation of blood (ie 450 ml) within 90 days before study day 1.
Description

Blood Donation Amount

Data type

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C1265611
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Similar models

Eligibility Parkinson's Disease (PD) NCT02071810

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. a signed and dated informed consent form before any study-specific screening procedure is performed.
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. aged between 18 and 45 years, inclusive.
boolean
C0001779 (UMLS CUI [1])
Healthy Medical History | Healthy Physical Examination | Healthy Laboratory Results | Healthy Vital signs | Healthy 12 lead ECG
Item
3. healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and digital 12-lead electrocardiogram (ecg).
boolean
C3898900 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C3898900 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C3898900 (UMLS CUI [3,1])
C1254595 (UMLS CUI [3,2])
C3898900 (UMLS CUI [4,1])
C0150404 (UMLS CUI [4,2])
C3898900 (UMLS CUI [5,1])
C0430456 (UMLS CUI [5,2])
Non-smoker | Tobacco use Number of cigarettes per day | Avoidance Tobacco use During Inpatient stay
Item
4. nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. must be able to abstain from smoking during the inpatient stay.
boolean
C0337672 (UMLS CUI [1])
C0543414 (UMLS CUI [2,1])
C3694146 (UMLS CUI [2,2])
C0870186 (UMLS CUI [3,1])
C0543414 (UMLS CUI [3,2])
C0347984 (UMLS CUI [3,3])
C0420512 (UMLS CUI [3,4])
Item Group
C0680251 (UMLS CUI)
Cardiovascular Diseases | Hypertensive disease | Liver diseases | Kidney Diseases | Respiration Disorders | Childhood asthma | Gastrointestinal Diseases | Endocrine System Diseases | Diabetes Mellitus | Dyslipidemia | Immune System Diseases | Dermatologic disorders | Hematological Disease | Nervous system disorder | Mental disorders
Item
1. any significant cardiovascular (e.g. hypertension), hepatic, renal, respiratory (e.g. childhood asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia), immunologic, dermatological, haematological, neurologic, or psychiatric disease.
boolean
C0007222 (UMLS CUI [1])
C0020538 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0035204 (UMLS CUI [5])
C0264408 (UMLS CUI [6])
C0017178 (UMLS CUI [7])
C0014130 (UMLS CUI [8])
C0011849 (UMLS CUI [9])
C0242339 (UMLS CUI [10])
C0021053 (UMLS CUI [11])
C0037274 (UMLS CUI [12])
C0018939 (UMLS CUI [13])
C0027765 (UMLS CUI [14])
C0004936 (UMLS CUI [15])
Nausea | Vomiting | Fever | Diarrhea
Item
2. acute disease state (e.g., nausea, vomiting, fever, diarrhoea) within 7 days before study day 1.
boolean
C0027497 (UMLS CUI [1])
C0042963 (UMLS CUI [2])
C0015967 (UMLS CUI [3])
C0011991 (UMLS CUI [4])
Drug abuse
Item
3. history of drug abuse within 1 year before study day 1.
boolean
C0013146 (UMLS CUI [1])
Alcoholic Intoxication, Chronic | Consumption Ethanol g/day | Consumption Wine g/day | Consumption Aperitif wine cl per day | Consumption Whisky g/day | Consumption Beer g/day
Item
4. history of alcoholism within 1 year before day 1. consumption of more than 50 g of ethanol per day (12.5 cl glass of 10° [10%] wine = 12 g; 4 cl of aperitif, 42° [42%] whiskey = 17 g; 25 cl glass of 3° [3%] beer = 7.5 g; 25 cl glass of 6° [6%] beer = 15 g
boolean
C0001973 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0001962 (UMLS CUI [2,2])
C0439417 (UMLS CUI [2,3])
C0001948 (UMLS CUI [3,1])
C0043188 (UMLS CUI [3,2])
C0439417 (UMLS CUI [3,3])
C0001948 (UMLS CUI [4,1])
C0678400 (UMLS CUI [4,2])
C0475212 (UMLS CUI [4,3])
C0439505 (UMLS CUI [4,4])
C0001948 (UMLS CUI [5,1])
C0475610 (UMLS CUI [5,2])
C0439417 (UMLS CUI [5,3])
C0001948 (UMLS CUI [6,1])
C0004922 (UMLS CUI [6,2])
C0439417 (UMLS CUI [6,3])
BIA 9-1067
Item
5. have previously received bia 9-1067.
boolean
C2933913 (UMLS CUI [1])
HIV antibody positive | Serology positive Hepatitis B Surface Antigens | Serology positive Hepatitis C Antibodies
Item
6. positive serologic findings for human immunodeficiency virus (hiv) antibodies, hepatitis b surface antigen (hbsag), and/or hepatitis c virus (hcv) antibodies.
boolean
C0920548 (UMLS CUI [1])
C0242089 (UMLS CUI [2,1])
C0019168 (UMLS CUI [2,2])
C0242089 (UMLS CUI [3,1])
C0166049 (UMLS CUI [3,2])
Urine drug screen positive | Amphetamines | Barbiturates | Benzodiazepines | Cannabinoids | Cocaine | Methadone | Opiates | Ecstasy - drug
Item
7. positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, mdma [3,4-methylenedioxy-methamphetamine; ecstasy]).
boolean
C0743300 (UMLS CUI [1])
C0002667 (UMLS CUI [2])
C0004745 (UMLS CUI [3])
C0005064 (UMLS CUI [4])
C0006864 (UMLS CUI [5])
C0009170 (UMLS CUI [6])
C0025605 (UMLS CUI [7])
C0376196 (UMLS CUI [8])
C0115471 (UMLS CUI [9])
Drug Allergy
Item
8. history of any clinically important drug allergy.
boolean
C0013182 (UMLS CUI [1])
Investigational New Drugs Recently | Pharmaceutical Preparations Recently
Item
9. prohibited treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product (imp) administration.
boolean
C0013230 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Consumption of Caffeine containing substance Excessive | Coffee | Tea | Hot chocolate drink | Soda | Consumption of GRAPEFRUIT Excessive | Consumption of product containing Grapefruit | Consumption of Alcoholic Beverages Excessive
Item
10. consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 24 before study day 1.
boolean
C0009830 (UMLS CUI [1,1])
C0565794 (UMLS CUI [1,2])
C0442802 (UMLS CUI [1,3])
C0009237 (UMLS CUI [2])
C0039400 (UMLS CUI [3])
C0452243 (UMLS CUI [4])
C0683086 (UMLS CUI [5])
C0009830 (UMLS CUI [6,1])
C0452456 (UMLS CUI [6,2])
C0442802 (UMLS CUI [6,3])
C0009830 (UMLS CUI [7,1])
C0681562 (UMLS CUI [7,2])
C0332256 (UMLS CUI [7,3])
C0995150 (UMLS CUI [7,4])
C0009830 (UMLS CUI [8,1])
C0001967 (UMLS CUI [8,2])
C0442802 (UMLS CUI [8,3])
Drugs, Non-Prescription | Herbal Supplements | Exception Acetaminophen occasional | Exception Aspirin occasional | Exception Vitamins occasional
Item
11. use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen [paracetamol], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before imp administration.
boolean
C0013231 (UMLS CUI [1])
C1504473 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0000970 (UMLS CUI [3,2])
C0521114 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0004057 (UMLS CUI [4,2])
C0521114 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0042890 (UMLS CUI [5,2])
C0521114 (UMLS CUI [5,3])
Blood Donation Amount
Item
12. donation of blood (ie 450 ml) within 90 days before study day 1.
boolean
C0005794 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
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