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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00680485 |
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 |
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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
Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | OPS108221 |
Study First Received: | April 14, 2008 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00680485 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
GSK580416 pleuromutilin oral dose ketoconazole interaction |
Bacterial Infections Clotrimazole Miconazole Tioconazole Ketoconazole |
Anti-Infective Agents Therapeutic Uses Antifungal Agents Infection Pharmacologic Actions |