Trials / Completed
CompletedNCT00896558
A Repeat Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK1322322 in Healthy Subjects
A Double-Blind, Parallel, Randomized, Placebo-Controlled, Repeat Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK1322322 in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This study will be the first repeat dose administration of GSK1322322 to investigate safety, tolerability, and pharmacokinetics in healthy subjects as well as elderly volunteer subjects. The study will also include a P450 probe drug (midazolam) to evaluate the effect of GSK1322322 to inhibit or induce CYP3A4 substrates.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GSK1322322/placebo | GSK1322322/placebo escalating doses from 500mg to 1500mg |
| DRUG | GSK1322322/placebo and midazolam | GSK1322322/placebo and 5mg midazolam |
Timeline
- Start date
- 2009-05-11
- Primary completion
- 2009-09-25
- Completion
- 2009-09-25
- First posted
- 2009-05-11
- Last updated
- 2017-06-22
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT00896558. Inclusion in this directory is not an endorsement.