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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00680485 |
Purpose
This study will evaluate the safety, tolerability and exposure of repeat escalating oral doses, a loading dose/maintenance dose regimen of GSK580416 and when co administered with ketoconazole, a PGP/CYP3A4 inhibitor.
| Condition | Intervention | Phase |
|---|---|---|
|
Bacterial Infection |
Drug: GSK580416 oral tablets (250 mg) Ketoconazole oral tablets (200 mg) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Safety Study |
| Official Title: | See Detailed Description |
| Estimated Enrollment: | 96 |
| Study Start Date: | June 2007 |
A three part study in healthy adult subjects to evaluate the safety, tolerability and pharmacokinetics of repeat escalating oral doses of GSK580416; the safety, tolerability, and pharmacokinetics of GSK580416 following a loading dose regimen; and the effect of ketoconazole on the pharmacokinetics of GSK580416
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | OPS108221 |
| Study First Received: | April 14, 2008 |
| Last Updated: | October 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00680485 History of Changes |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
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GSK580416 pleuromutilin oral dose ketoconazole interaction |
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Bacterial Infections Anti-Infective Agents Therapeutic Uses Antifungal Agents |
Ketoconazole Infection Pharmacologic Actions |