A First Time in Human Study in Healthy Male Volunteers for Compound GSK557296.
This study has been completed.
Information provided by (Responsible Party):
First received: October 23, 2007
Last updated: March 15, 2012
Last verified: February 2011
A study conducted on healthy volunteers to determine the safety, tolerability and affect on the human body by experimental drug GSK557296.
Obstetric Labour, Premature
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||A Two-Part Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Oral Doses of GSK557296 in a Randomized, Single-Blind, Placebo-Controlled, Dose-Rising Design, and to Evaluate the Effect of Food on Single Oral Doses of GSK557296 in Healthy Adult Subjects|
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Safety tests up to 24 hrs after dose 12-lead ECG to look at the heart prior to dose and up to 24 hours after Dual-lead telemetry to monitor the heart rhythms for 20 hours prior to dosing and up to 12 hours after dosing Periodic vital signs [ Time Frame: 24 Hours ]
Secondary Outcome Measures:
- Blood tests to study how long the drug stays in your blood [ Time Frame: 24 Hours ]
|Study Start Date:||October 2007|
Other Name: GSK557296
Contacts and Locations