ID

40797

Description

Study ID: 103933 Clinical Study ID: NKV103933 Study Title: A non-randomised, open label, two period cross-over study to determine the excretion balance and metabolic disposition of [14C]-GW679769, administered as single doses of an oral solution and an intravenous infusion to healthy male subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced Protocol ID: NKV103933 The eligibility to participate was determined during a screening visit within 21 days prior to first dosing day. The study consisted of two dosing periods, each consisting of predose visit, monitoring after dose administration and prior to discharge visit. Dosing periods were separated by a wash-out period of 43 days. The Drug Screening and Alcohol Breath Test form has to be filled in at screening and at both pre-dose treatment examinations.

Keywords

Versions (1)
  1. 5/15/20 5/15/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 15, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Study of Casopitant Pharmacokinetics in Healthy Males, NKV103933

English

Drug Screen, Alcohol Breath Test

1 forms  
Administrative Data
Description

Administrative Data

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
Visit Type
Description

Visit Type

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Drug Screening
Description

Drug Screening

Alias
UMLS CUI-1
C0451130
Date and time of sample taken
Description

Drug screen - Date and time sample taken

Data type

datetime

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Cocaine
Description

If positive, exclude subject from the study.

Data type

text

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0009170
Amphetamines
Description

If positive, exclude subject from the study.

Data type

text

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0002667
Benzodiazepines
Description

If positive, exclude subject from the study.

Data type

text

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0005064
Cannabinoids
Description

If positive, exclude subject from the study.

Data type

text

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0006864
Opiates
Description

If positive, exclude subject from the study.

Data type

text

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0376196
Barbiturates
Description

If positive, exclude subject from the study.

Data type

text

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0004745
Methadone
Description

If positive, exclude subject from the study.

Data type

text

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0025605
Cotinine
Description

If positive, exclude subject from the study.

Data type

text

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0202363
Alcohol Breath Test
Description

Alcohol Breath Test

Alias
UMLS CUI-1
C0202306
Date sample taken
Description

Alcohol Breath Test - Date sample taken

Data type

date

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C0011008
Results
Description

If positive, exclude subject from the study.

Data type

text

Alias
UMLS CUI [1]
C0202306
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Similar models

Drug Screen, Alcohol Breath Test

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
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
Visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit Type
Code List
Visit Type
CL Item
Screening (Screening)
(Comment:en)
CL Item
Treatment Period 1 Predose (Treatment Period 1 Predose)
(Comment:en)
CL Item
Treatment Period 2 Predose (Treatment Period 2 Predose)
(Comment:en)
Item Group
Drug Screening
C0451130 (UMLS CUI-1)
Drug screen - Date and time sample taken
Item
Date and time of sample taken
datetime
C0373483 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item
Cocaine
text
C0373483 (UMLS CUI [1,1])
C0009170 (UMLS CUI [1,2])
Drug Screen, Cocaine
Code List
Cocaine
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Amphetamines
text
C0373483 (UMLS CUI [1,1])
C0002667 (UMLS CUI [1,2])
Drug Screen, Amphetamines
Code List
Amphetamines
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Benzodiazepines
text
C0373483 (UMLS CUI [1,1])
C0005064 (UMLS CUI [1,2])
Drug Screen, Benzodiazepines
Code List
Benzodiazepines
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Cannabinoids
text
C0373483 (UMLS CUI [1,1])
C0006864 (UMLS CUI [1,2])
Drug Screen, Cannabinoids
Code List
Cannabinoids
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Opiates
text
C0373483 (UMLS CUI [1,1])
C0376196 (UMLS CUI [1,2])
Drug Screen, Opiates
Code List
Opiates
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Barbiturates
text
C0373483 (UMLS CUI [1,1])
C0004745 (UMLS CUI [1,2])
Drug Screen, Barbiturates
Code List
Barbiturates
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Methadone
text
C0373483 (UMLS CUI [1,1])
C0025605 (UMLS CUI [1,2])
Drug Screen, Methadone
Code List
Methadone
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Cotinine
text
C0373483 (UMLS CUI [1,1])
C0202363 (UMLS CUI [1,2])
Drug Screen, Cotinine
Code List
Cotinine
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item Group
Alcohol Breath Test
C0202306 (UMLS CUI-1)
Alcohol Breath Test - Date sample taken
Item
Date sample taken
date
C0202306 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Results
text
C0202306 (UMLS CUI [1])
Alcohol Breath Test Result
Code List
Results
CL Item
Positive (Positive)
CL Item
Negative (Negative)
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