drugset / Trial / NCT00975936

Phase 0 Microdose Study

NCT00975936

Phase 1 Completed 12 enrolled GlaxoSmithKline
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

EvaluationDrugModalityDoseRoute
Subject GSK706769 Unknown 50 ug Oral
Subject Ketoconazole Small molecule 200 mg Oral

Indications