A First Time in Human Study in Healthy Male Volunteers for Compound GSK557296. - Full Text View

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

This study is not yet open for participant recruitment.
Verified by GlaxoSmithKline, October 2007

Sponsored by:	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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Crossover Assignment, Pharmacokinetics Study

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

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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:

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

Contacts and Locations

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

Locations


United States, Indiana
	GSK Clinical Trials Call Center	Not yet recruiting
	Evansville, Indiana, United States, 47714
	Contact: Stewart Smith 877-379-3718

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Study ID Numbers:	OTB109039
First Received:	October 23, 2007
Last Updated:	October 23, 2007
ClinicalTrials.gov Identifier:	NCT00549211
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Safety,

Tolerability,

Healthy Subjects,

Pharmacokinetics

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on October 10, 2008