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

Premature Ejaculation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00549211
• Other study ID #: OTB109039
• Status: Completed
• Phase: Phase 1
• First received: October 23, 2007
• Last updated: March 15, 2012
• Start date: October 2007

Study information

• Verified date: February 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Obstetric Labour, Premature
• Premature Birth
• Premature Ejaculation

Intervention

Drug:
• GSK557296

Locations

Country	Name	City	State
United States	GSK Investigational Site	Evansville	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		24 Hours
Secondary	Blood tests to study how long the drug stays in your blood		24 Hours