NCT01202214

Repeat Dose Safety Study for Compound to Treat Asthma

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Accenture · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to describe the safety and tolerability of single and repeat oral doses of GSK1440115 in healthy volunteers.

Detailed description

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	1440115
DRUG	Placebo	matching placebo

Timeline

• Start date: 2010-09-01
• First posted: 2010-09-15
• Last updated: 2011-01-31

Locations

1 site across 1 country: Australia