Repeat Dose Safety Study for Compound to Treat Asthma
The purpose of this study is to describe the safety and tolerability of single and repeat oral doses of GSK1440115 in healthy volunteers.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
|Official Title:||A Randomized, Single-Blind, Placebo Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GSK1440115 After a Single Dose and 7 Days of Repeat Dosing in Healthy Volunteers|
- Safety and tolerability assessments consisting of Adverse Events, ECGs, vital signs, clinical observations, and clinical laboratory tests [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- Plasma drug concentration versus time curve [AUC (0-t), AUC [0-∞], AUC(0-t)], maximum Cmax, tmax, and t1/2 of GSK1140115 as data permit [ Time Frame: Duration of dosing ] [ Designated as safety issue: No ]
- Blood pressure (BP) and heart rate (HR) [ Time Frame: Duration of dosing ] [ Designated as safety issue: Yes ]
- Peak expiratory flow rate (PEFR) [ Time Frame: Duration of Dosing ] [ Designated as safety issue: No ]
|Study Start Date:||September 2010|
|Experimental: Active drug||Drug: 1440115|
|Placebo Comparator: Placebo||
This study is the first administration of GSK1440115 to humans. GSK1440115 is a urotensin II receptor antagonist which is being developed for the treatment of asthma. This will be a two-part study to evaluate the safety, tolerability, and pharmacokinetics of single (Part A) and repeat (Part B) oral doses of GSK1440115 in healthy adult male and female (of non-child bearing potential) subjects. This study will be a randomized, single-blind, placebo-controlled, dose escalation design. Part A will evaluate a single dose of GSK1440115. Part B will evaluate repeat daily doses for 7 days.