GSK2190915 Safety and Pharmacokinetic Study in Healthy Japanese Subjects

NCT00955383 PHASE1 COMPLETED

GSK2190915 is currently in development for the treatment of asthma. This study aims to assess the safety and tolerability of single doses of GSK2190915 in healthy Japanese subjects. The study will also look at the pharmacokinetics (PK) and pharmacodynamics (PD) of single doses of GSK2190915 and aims to characterise the PK/PD relationship in healthy Japanese subjects. Twelve healthy Japanese subjects will take part in this single escalating dose study and subjects will receive one of five possible treatments, 10 mg, 50 mg, 150 mg, 450 mg GSK2190915 or placebo in each treatment period. Blood samples (for safety, pharmacokinetics and pharmacodynamics), urine samples (for safety and pharmacodynamics) and ECGs, blood pressure readings, physical examinations and a review of adverse events will take place at a number of timepoints pre and post each dose. A minimum 7 day washout between treatment periods will be required. Regardless if a subject completes or prematurely withdraws from the study, a follow up visit will be completed 7-10 days following last dose.

Details

Lead sponsor	GlaxoSmithKline
Phase	PHASE1
Status	COMPLETED
Enrolment	12
Start date	Fri Aug 14 2009 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Mon Oct 12 2009 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Asthma

Interventions

• GSK2190915
• Placebo

Countries

Germany