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

NCT00680485 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2017-01-20

No results posted yet for this study

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.

Conditions

Interventions

DRUG

GSK580416 oral tablets (250 mg) Ketoconazole oral tablets (200 mg)

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • Australia

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00680485 on ClinicalTrials.gov