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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00975936 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Ketoconazole Drug: [14C]-GSK706769 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | A Human Phase 0, Microdose Drug-Drug Interaction Study With [14C]-GSK706769 and Ketoconazole in Healthy Male Volunteers |
| Enrollment: | 12 |
| Study Start Date: | September 2009 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: [14C]-GSK706769
Single dose of 50µg [14C]-GSK706769 containing 250 nCi
|
Drug: [14C]-GSK706769
50µg [14C]-GSK706769 containing 250 nCi
|
|
Experimental: [14C]-GSK706769 + Ketoconazole
An oral, 5-day repeat dose of 200 mg Ketoconazole (Q12) with a concomitant single oral dose of 50 µg [14C]-GSK706769 containing 250 nCi on day 3.
|
Drug: Ketoconazole
200 mg Ketoconazole (Q12)
Drug: [14C]-GSK706769
50µg [14C]-GSK706769 containing 250 nCi
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Study Director, GSK |
| ClinicalTrials.gov Identifier: | NCT00975936 History of Changes |
| Other Study ID Numbers: | 113191 |
| Study First Received: | September 11, 2009 |
| Last Updated: | January 28, 2010 |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
|
Phase 0 Microdose Ketoconazole Drug-Drug Interaction |
|
Ketoconazole 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antifungal Agents Anti-Infective Agents Therapeutic Uses |