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

Tracking Information

First Received Date ^ICMJE

October 23, 2007

Last Updated Date

October 9, 2008

Start Date ^ICMJE

October 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00549211 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Blood tests to study how long the drug stays in your blood [ Time Frame: 24 Hours ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind, Crossover Assignment, Pharmacokinetics Study

Condition ^ICMJE

Premature Ejaculation

Intervention ^ICMJE

Drug: GSK557296

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00549211

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

OTB109039

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP