A First Time in Human Study in Healthy Male Volunteers for Compound GSK557296.

Phase 1

Completed

• Conditions: Obstetric Labour, Premature; Premature Ejaculation

• Registration Number: NCT00549211
• Lead Sponsor: GlaxoSmithKline

Brief Summary

A study conducted on healthy volunteers to determine the safety, tolerability and affect on the human body by experimental drug GSK557296.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-23
• Study First Submitted QC: 2007-10-23
• Study First Posted: 2007-10-25
• Status Verified: 2011-02
• Last Update Submitted: 2012-03-15
• Last Update Posted: 2012-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 42

Inclusion Criteria

• Healthy males who are 18 to 45 years of age
• Body mass index between 19 and 30 with a body weight greater than 110 pounds and deemed healthy by a physician
• Non-smokers

Exclusion Criteria

• Alcohol consumption averaging more than 7 drinks per week
• Positive for Hepatitis C antibody, Hepatitis B antigen or HIV
• Any use of prescription drugs or non prescription drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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	24 Hours

Secondary Outcome Measures

Name	Time	Method
Blood tests to study how long the drug stays in your blood	24 Hours

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Evansville, Indiana, United States