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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00664365 |
This study is the first administration of GSK958108 to man. The study will evaluate the safety, tolerability and pharmacokinetics of single ascending doses of GSK958108 and evaluate the effect of food on GSK958108 pharmacokinetics
Condition | Intervention | Phase |
---|---|---|
Premature Ejaculation |
Drug: GSK958108 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Crossover Assignment, Safety Study |
Official Title: | A Single Blind, Randomised, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK958108 in Healthy Male Subjects |
Estimated Enrollment: | 20 |
Study Start Date: | April 2008 |
Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
History of regular alcohol consumption within 6 months of the study defined as:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | SPE111154 |
Study First Received: | April 10, 2008 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00664365 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
FTIH, 5HT1a antagonist, GSK958108, Premature ejaculation. |
Sexual Dysfunctions, Psychological Mental Disorders Healthy Serotonin |
Sexual Dysfunctions, Psychological Mental Disorders Sexual and Gender Disorders |