NCT01818024

A Study to Investigate the Safety Tolerability Pharmacokinetics, and Pharmacodynamics of Inhaled and Intravenous GSK2862277 in Healthy Volunteers

A Three Part, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Repeat Doses of Inhaled and Intravenous GSK2862277 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This will be a 3 part study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat doses of GSK2862277 administered via inhalation (IH) or intravenous (IV) routes in healthy subjects. Part 1 of this study will involve an initial assessment of safety, tolerability and pharmacokinetics of GSK286227, via single escalating intravenous doses, compared to a predecessor molecule, GSK1995057. After completion of Part 1 an interim data review will occur which will assess key comparability criteria to inform progression to Part 2 of the study. Part 2 of the study will involve single doses of GSK2862277 at a level predicted to be at or close to therapeutic dose levels. Part 2 will investigate both intravenous and inhaled routes of administration, in sequential manner, respectively. An interim data review will also occur after completion of Part 2, where all data accumulated previously will be assessed to examine appropriateness to progress to Part 3. Part 3 of the study will involve 5 days of repeat dosing via both inhaled and intravenous routes using the same dose administered in Part 2.

Conditions

• Respiratory Disorders

Interventions

Type	Name	Description
DRUG	Single IV dose of GSK2862277	GSK2862277 solution available in a 40 mg vial for IV administration.
DRUG	Matching placebo single dose IV infusion	Matching placebo solution available for IV administration.
DRUG	Single IH dose of GSK2862277	GSK2862277 nebulised solution available in a 40 mg vial for IH administration.
DRUG	Matching placebo single dose IH	Matching placebo nebulised solution available for IH administration.
DRUG	Repeat IV dose of GSK2862277	GSK2862277 solution available in a 40 mg vial for IV administration.
DRUG	Matching placebo repeat dose IV infusion	Matching placebo solution available for IV administration.
DRUG	Repeat IH dose selected of GSK2862277 from Part 2	GSK2862277 nebulised solution available in a 40 mg vial for IH administration.
DRUG	Matching placebo repeat dose IH	Matching placebo nebulised solution available for IH administration.

Timeline

• Start date: 2013-02-22
• Primary completion: 2013-10-25
• Completion: 2013-10-25
• First posted: 2013-03-26
• Last updated: 2017-05-15

Locations

1 site across 1 country: United Kingdom