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A First Time in Human Study in Healthy Male Volunteers for Compound GSK557296.
This study has been completed.
Study NCT00549211   Information provided by GlaxoSmithKline
First Received: October 23, 2007   Last Updated: October 9, 2008   History of Changes

October 23, 2007
October 9, 2008
October 2007
 
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 ]
Same as current
Complete list of historical versions of study NCT00549211 on ClinicalTrials.gov Archive Site
Blood tests to study how long the drug stays in your blood [ Time Frame: 24 Hours ]
Same as current
 
A First Time in Human Study in Healthy Male Volunteers for Compound GSK557296.
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

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

 
Phase I
Interventional
Treatment, Randomized, Single Blind, Crossover Assignment, Pharmacokinetics Study
Premature Ejaculation
Drug: GSK557296
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
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
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00549211
Study Director, GSK
OTB109039
GlaxoSmithKline
 
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
October 2008

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