NCT00680485

Evaluation of the Safety, Tolerability and Pharmacokinetics of Repeat Oral Doses of GSK580416

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (planned)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

Conditions

• Bacterial Infection
• Infections, Bacterial

Interventions

Type	Name	Description
DRUG	GSK580416 oral tablets (250 mg) Ketoconazole oral tablets (200 mg)

Timeline

• Start date: 2007-06-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2008-05-20
• Last updated: 2017-01-20

Locations

1 site across 1 country: Australia