ID

40798

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. The Continuous 12-Lead ECG Form has to be filled in during Treatment Period 1.

Palavras-chave

  1. 15/05/2020 15/05/2020 -
Titular dos direitos

GlaxoSmithKline

Transferido a

15 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

Continuous 12-Lead ECG

  1. StudyEvent: ODM
    1. Continuous 12-Lead ECG
Administrative Data
Descrição

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descrição

Subject Identifier

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Descrição

Visit Date

Tipo de dados

date

Alias
UMLS CUI [1]
C1320303
Continuous 12-Lead ECG
Descrição

Continuous 12-Lead ECG

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C0549178
Start date of ECG
Descrição

Continuous 12-Lead ECG start date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C0808070
Start time of ECG
Descrição

Continuous 12-Lead ECG start time

Tipo de dados

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C1301880
End time of ECG
Descrição

Continuous 12-Lead ECG end time

Tipo de dados

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C1522314
Result of the ECG
Descrição

Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. Complete additional ECG Abnormalities page if clinically significant abnormalities are present.

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C1274040

Similar models

Continuous 12-Lead ECG

  1. StudyEvent: ODM
    1. Continuous 12-Lead ECG
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])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Continuous 12-Lead ECG
C0430456 (UMLS CUI-1)
C0549178 (UMLS CUI-2)
Continuous 12-Lead ECG start date
Item
Start date of ECG
date
C0430456 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Continuous 12-Lead ECG start time
Item
Start time of ECG
time
C0430456 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
Continuous 12-Lead ECG end time
Item
End time of ECG
time
C0430456 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
Item
Result of the ECG
integer
C0430456 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (3)
CL Item
No result (not available) (4)

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