drugset / Trial / NCT00975936
Phase 0 Microdose Study
Non-randomizedSingle-groupOpen-labelBasic science
Summary
This study is a methodology study to evaluate a microdose strategy for Drug-Drug Interaction (DDI) which will be useful in the evaluation of the backup compounds for GSK706769, as well as possibly other assets. The safety, tolerability and pharmacokinetics will be evaluated in healthy adult subjects. This will be an open-label fixed-sequence 2-period study in healthy male volunteers after oral administration of \[14C\]-GSK706769 alone and in the presence of Ketoconazole.
Timeline
- Start
- 2009-09-21
- Primary completion
- 2009-11-12
- Completion
- 2009-11-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GSK706769 | Unknown | 50 ug | Oral |
| Subject | Ketoconazole | Small molecule | 200 mg | Oral |