Trials / Completed
CompletedNCT00550225
Succinate Salt Version of GSK961081 for Healthy Volunteers
A Randomised, Double-blind, Dose Escalating Study in Healthy Volunteers to Assess the Safety, Tolerability, Extra Pulmonary Pharmacodynamics and Pharmacokinetics of Single Doses of GSK961081 (Succinate Salt)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Theravance Biopharma · Industry
- Sex
- Male
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
Salt Bridging study for GSK961081
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GSK961081 | GSK961081 edisylate and succinate will be administered as capsules via DISKUS inhaler formulated with lactose as a vehicle to make 12.5 milligrams. GSK961081 succinate will be given in a dose-ascending manner with a starting dose of 300 micrograms. The dose of GSK961081 edisylate is 1500 micrograms. |
| DRUG | GSK961081 matching placebo | GSK961081 matching placebo formulated with lactose only as a vehicle to 12.5 milligrams will be administered via the DISKUS inhaler. |
Timeline
- Start date
- 2007-11-29
- Primary completion
- 2008-01-08
- Completion
- 2008-01-08
- First posted
- 2007-10-29
- Last updated
- 2021-10-06
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT00550225. Inclusion in this directory is not an endorsement.