ID
25692
Description
Demography, Eligibility - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876 Study ID: 100789 Clinical Study ID: NKV100789 Study Title: A two-part, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of single intravenous doses of GW679769 when administered alone and in combination with intravenous or oral doses of dexamethasone in healthy adult subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00291876 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
Keywords
Versions (2)
- 9/10/17 9/10/17 -
- 9/10/17 9/10/17 -
Uploaded on
September 10, 2017
DOI
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License
Creative Commons BY-NC 3.0
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Demography, Eligibility - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876
Demography, Eligibility - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876
Description
Eligibility
Alias
- UMLS CUI-1
- C0013893
Description
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Description
healthy between 18 and 55 years
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3898900
- UMLS CUI [1,2]
- C0001779
Description
childbearing potential
Data type
boolean
Alias
- UMLS CUI [1]
- C3831118
Description
BMI
Data type
boolean
Alias
- UMLS CUI [1]
- C1305855
Description
informed consent
Data type
boolean
Alias
- UMLS CUI [1]
- C0021430
Description
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Description
screening finding
Data type
boolean
Alias
- UMLS CUI [1]
- C1409616
Description
allergy dexamethasone
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013182
- UMLS CUI [1,2]
- C0011777
Description
osteoporosis
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0029456
- UMLS CUI [1,2]
- C1141639
Description
concomitant medication
Data type
boolean
Alias
- UMLS CUI [1]
- C2347852
Description
medical history
Data type
boolean
Alias
- UMLS CUI [1]
- C0262926
Description
medical history
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0205082
Description
cytochrome P450 3A inducer or inhibitors
Data type
boolean
Alias
- UMLS CUI [1]
- C3830625
- UMLS CUI [2]
- C3830624
Description
herbal or dietary supplements
Data type
boolean
Alias
- UMLS CUI [1]
- C0242295
- UMLS CUI [2]
- C1504473
Description
blood donor
Data type
boolean
Alias
- UMLS CUI [1]
- C0005795
Description
investigational drug
Data type
boolean
Alias
- UMLS CUI [1]
- C0013230
Description
drug screeing
Data type
boolean
Alias
- UMLS CUI [1]
- C0743295
Description
alcohol consumption
Data type
boolean
Alias
- UMLS CUI [1]
- C0001948
Description
smoking
Data type
boolean
Alias
- UMLS CUI [1]
- C0543414
Description
HIV, Hepatitis B or Hepatitis C test positive
Data type
boolean
Alias
- UMLS CUI [1]
- C1321876
- UMLS CUI [2]
- C2363788
- UMLS CUI [3]
- C2363789
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Demography, Eligibility - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876
C0040223 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
C0001779 (UMLS CUI [1,2])
C0011777 (UMLS CUI [1,2])
C1141639 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,2])
C3830624 (UMLS CUI [2])
C1504473 (UMLS CUI [2])
C2363788 (UMLS CUI [2])
C2363789 (UMLS CUI [3])