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
NCT number | NCT00549211 |
Other study ID # | OTB109039 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | October 23, 2007 |
Last updated | March 15, 2012 |
Start date | October 2007 |
Verified date | February 2011 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
A study conducted on healthy volunteers to determine the safety, tolerability and affect on the human body by experimental drug GSK557296.
Status | Completed |
Enrollment | 42 |
Est. completion date | |
Est. primary completion date | |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | GSK Investigational Site | Evansville | Indiana |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
United States,
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 |
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