Skip to main content
OpenTrials
Completed

NCT Number: NCT00549211

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obstetric Labour, Premature Ejaculatory Dysfunction Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Premature Ejaculation Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Evansville, Indiana, 47714, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GSK557296

Drug

Primary outcomes

  1. 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 outcomes

  1. Blood tests to study how long the drug stays in your blood

    Time frame: 24 Hours

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2007
First posted
Oct 25, 2007
Registry last updated
Mar 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.