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

This study has been completed.

First Received on October 23, 2007. Last Updated on October 14, 2010 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00549211

Purpose

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

Condition	Intervention	Phase
Premature Ejaculation	Drug: GSK557296	Phase I

Study Type:	Interventional
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 ]

Estimated Enrollment:	42
Study Start Date:	October 2007
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Other Name: GSK557296

Eligibility

Criteria

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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549211

Locations

United States, Indiana
GSK Investigational Site
Evansville, Indiana, United States, 47714

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00549211 History of Changes
Other Study ID Numbers:	OTB109039
Study First Received:	October 23, 2007
Last Updated:	October 14, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Safety,
Tolerability,
Healthy Subjects,
Pharmacokinetics

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 12, 2012