ID

41002

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 Demography Form has to be filled in at the Screening visit. Centre Number from Cover Sheets is included.

Keywords

Versions (1)
  1. 6/10/20 6/10/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 10, 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

Demography

1 forms  
  1. StudyEvent: ODM
    1. Demography
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
Centre Number
Description

Centre Number

Data type

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Only Male gender can be selected in this Form.

Data type

text

Alias
UMLS CUI [1]
C0079399
Ethnicity - tick one
Description

• Hispanic or Latino: A person of Cuban, Mexican, Puerto Rican, South American or other Spanish culture or origin, regardless of race Note: If the subject does not meet the definition above, tick Not Hispanic or Latino. • Not Hispanic or Latino: Neither Hispanic or Latino

Data type

integer

Alias
UMLS CUI [1]
C0015031
Race - Tick all that apply
Description

Race - Tick all that apply

Alias
UMLS CUI-1
C0034510
[11] African American/African Heritage
Description

African American/African Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0085756
UMLS CUI [2]
C0027567
[12] American Indian or Alaskan Native
Description

American Indian or Alaskan Native

Data type

boolean

Alias
UMLS CUI [1]
C1515945
[13] Asian - Central/South Asian Heritage
Description

Central/South Asian Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0238696
UMLS CUI [2]
C1519427
[14] Asian - East Asian Heritage
Description

East Asian Heritage

Data type

boolean

Alias
UMLS CUI [1]
C4540996
[15] Asian - Japanese Heritage
Description

Japanese Heritage

Data type

boolean

Alias
UMLS CUI [1]
C1556094
[16] Asian - South East Asian Heritage
Description

South East Asian Heritage

Data type

boolean

Alias
UMLS CUI [1]
C0238697
[17] Native Hawaiian or Other Pacific Islander
Description

Native Hawaiian or Other Pacific Islander

Data type

boolean

Alias
UMLS CUI [1]
C1513907
[18] White - Arabic/North African Heritage
Description

Arabic/North African Heritage

Data type

boolean

Alias
UMLS CUI [1,1]
C0238604
UMLS CUI [1,2]
C2698217
[19] White - White/Caucasian/European Heritage
Description

Caucasians

Data type

boolean

Alias
UMLS CUI [1]
C0043157
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Similar models

Demography

1 forms
  1. StudyEvent: ODM
    1. Demography
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])
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Gender
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
Ethnicity - tick one
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity - tick one
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item Group
Race - Tick all that apply
C0034510 (UMLS CUI-1)
African American/African Heritage
Item
[11] African American/African Heritage
boolean
C0085756 (UMLS CUI [1])
C0027567 (UMLS CUI [2])
American Indian or Alaskan Native
Item
[12] American Indian or Alaskan Native
boolean
C1515945 (UMLS CUI [1])
Central/South Asian Heritage
Item
[13] Asian - Central/South Asian Heritage
boolean
C0238696 (UMLS CUI [1])
C1519427 (UMLS CUI [2])
East Asian Heritage
Item
[14] Asian - East Asian Heritage
boolean
C4540996 (UMLS CUI [1])
Japanese Heritage
Item
[15] Asian - Japanese Heritage
boolean
C1556094 (UMLS CUI [1])
South East Asian Heritage
Item
[16] Asian - South East Asian Heritage
boolean
C0238697 (UMLS CUI [1])
Native Hawaiian or Other Pacific Islander
Item
[17] Native Hawaiian or Other Pacific Islander
boolean
C1513907 (UMLS CUI [1])
Arabic/North African Heritage
Item
[18] White - Arabic/North African Heritage
boolean
C0238604 (UMLS CUI [1,1])
C2698217 (UMLS CUI [1,2])
Caucasians
Item
[19] White - White/Caucasian/European Heritage
boolean
C0043157 (UMLS CUI [1])
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