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Drug Interaction Study to Investigate Co-administration of GW642444M With Ketoconazole

NCT00866515 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-07-18

No results posted yet for this study

Summary

This will be a single-centre, randomised, double blind, placebo controlled, two-way crossover study in healthy male and female subjects. There will be two treatment periods each consisting of 7 days. During each treatment period subjects will receive single doses of ketoconazole or placebo on the morning of days 1-6 with a single dose of GW642444M on the morning of Day 5.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Ketoconazole + GW642444M

Ketoconazole 400mg OD days 1-6, GW642444M 25ug single dose on D5

DRUG

Placebo + GW642444M

Placebo to match D1-6 + GW642444M 25ug single dose on D5

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2008-12-22
Primary Completion
2009-03-27
Completion
2009-03-27

Countries

  • Australia

Study Locations

More Related Trials

Entities

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 NCT00866515 on ClinicalTrials.gov