At a glance
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A Single-centre, Double-blind (Sponsor Open), Placebo Controlled Two Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of GSK2292767 as a Dry Powder in Healthy Participants Who Smoke Cigarettes
In Brief
A Phase 1 clinical trial evaluating GSK2292767 50 μg, GSK2292767 500 μg, and 1 other intervention for Asthma. Completed, enrolled 38 participants across 1 site.
Detailed Summary
This study is the first administration of GSK2292767 to humans. The study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and repeat inhaled doses of GSK2292767 in healthy smokers. This study is intended to provide sufficient confidence in the safety of the molecule and preliminary information on target engagement to allow progression to further repeat dose and proof of mechanism studies. This is a two part, single site, randomized, double-blind (sponsor open), placebo controlled study. Part A will consist of two 3-period interlocking cohorts to evaluate the safety, tolerability and pharmacokinetics of ascending single doses of GSK2292767 administered as a dry powder inhalation. Part B is planned to follow Part A and progression will be based on an acceptable safety, tolerability and pharmacokinetic profiles. Subjects will receive repeat doses of GSK2292767 once daily for 14 days during Part B.
Study Details
Timeline
Interventions
GSK2292767 50 μg blended with lactose and magnesium stearate per blister as powder for inhalation
GSK2292767 500 μg blended with lactose and magnesium stearate per blister as powder for inhalation
Lactose as powder for inhalation