Last updated: 11/07/2018 18:10:05
A Study to Investigate whether there is a Pharmacokinetic Interaction between 141W94 and Ketoconazole following their Co-Administration to Healthy Male Volunteers.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Study to Investigate whether there is a Pharmacokinetic Interaction between 141W94 and Ketoconazole following their Co-Administration to Healthy Male Volunteers.
Trial description: A Study to Investigate whether there is a Pharmacokinetic Interaction between 141W94 and Ketoconazole following their Co-Administration to Healthy Male Volunteers.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Polk RE, Crouch MA, Israel DS, Pastor A, Sadler BM, Chittick GE, Symonds WT, Gouldin W, Lou Y. Pharmacokinetic interaction between ketoconazole and amprenavir after single doses in healthy men. Pharmacotherapy. 1999;19(12):1378-84.
Polk RE, Israel DS, Pastor A, Sadler BM, Chittick GE, Symonds WT, Crouch M, Gouldin W, Lou Y, Rawls C, Bye A. Pharmacokinetic interaction between Ketoconazole and the HIV protease inhibitor 141W94 after single dose administration to normal volunteers. Proceedings and Abstracts of the 37th Interscience Conference on Antimicrobial Agents and Chemotherapy, September 1997, Toronto, Canada, Abstract A61
Polk RE, Israel DS, Pastor A, Sadler BM, Chittick GE, Symonds WT, Lou Y, Crouch M. Effects of the HIV-1 protease inhibitor, Amprenavir [141W94], and Ketoconazole on cytochrome P450 3A4 activity as measured by the erythromycin breath test. Proceedings and Abstracts of the 5th Conference on Retroviruses and Opportunistic Infections, January 1988, Chicago, USA, Abstract 341
Medical condition
Infection, Human Immunodeficiency Virus
Product
amprenavir
Collaborators
Not applicable
Study date(s)
December 1996 to March 1997
Type
Not applicable
Phase
1
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
1997-10-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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