ID

40850

Descrição

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. This Form has to be filled in at the subject completion or withdrawal from the study.

Palavras-chave

Versões (1)
  1. 26/05/2020 26/05/2020 -
Titular dos direitos

GlaxoSmithKline

Transferido a

26 de maio de 2020

DOI

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Licença

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

Inglês

Study Conclusion, Pregnancy Information

1 Formulários  
Administrative Data
Descrição

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descrição

Subject Identifier

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Date
Descrição

Date

Tipo de dados

date

Alias
UMLS CUI [1]
C0011008
Study Conclusion
Descrição

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
Date of subject completion or withdrawal
Descrição

Date of subject completion or withdrawal

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0422727
UMLS CUI [2]
C1549507
Was the subject withdrawn from the study?
Descrição

Was the subject withdrawn from the study?

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0422727
If Yes, check the primary reason for withdrawal:
Descrição

If the reason was an adverse event, record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1549995
Other, specify
Descrição

Other reason for withdrawal, specification

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C3840932
UMLS CUI [1,3]
C1521902
Pregnancy Information
Descrição

Pregnancy Information

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did a female partner of the male subject become pregnant during the study?
Descrição

If Yes, complete Pregnancy Notification form.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0919624
UMLS CUI [1,2]
C3828490
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Similar models

Study Conclusion, Pregnancy Information

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Date of subject completion or withdrawal
Item
Date of subject completion or withdrawal
date
C0011008 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
C1549507 (UMLS CUI [2])
Was the subject withdrawn from the study?
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
If Yes, check the primary reason for withdrawal:
text
C0422727 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
The primary reason for withdrawal
Code List
If Yes, check the primary reason for withdrawal:
CL Item
Adverse event  (1)
CL Item
Lost to follow-up (2)
CL Item
Protocol violation (3)
CL Item
Subject decided to withdraw from the study (4)
CL Item
Sponsor terminated study (6)
CL Item
Other, specify (Z)
Other reason for withdrawal, specification
Item
Other, specify
text
C0422727 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item Group
Pregnancy Information
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did a female partner of the male subject become pregnant during the study?
text
C0919624 (UMLS CUI [1,1])
C3828490 (UMLS CUI [1,2])
Pregnancy during the study
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Applicable (subject is female, female partner not of childbearing potential or no female partner)  (X)
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