NCT00975936

Phase 0 Microdose Study

A Human Phase 0, Microdose Drug-Drug Interaction Study With [14C]-GSK706769 and Ketoconazole in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Autoimmune Diseases

Interventions

Type	Name	Description
DRUG	[14C]-GSK706769	50µg \[14C\]-GSK706769 containing 250 nCi
DRUG	Ketoconazole	200 mg Ketoconazole (Q12)

Timeline

• Start date: 2009-09-21
• Primary completion: 2009-11-12
• Completion: 2009-11-12
• First posted: 2009-09-14
• Last updated: 2017-06-27

Locations

1 site across 1 country: United States