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FTIH Study With GSK958108

NCT00664365 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2017-08-01

No results posted yet for this study

Summary

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

Conditions

  • Premature Ejaculation

Interventions

DRUG

GSK958108

GSK958108 oral tablets will be available with dosing strengths of 1 milligram, 5 milligrams, 25 milligrams and 50 milligrams. It will be a brownish-yellow film coated round shape tablet. The tablets have to be swallowed completely with 240 milliliters of water, without chewing over a period of five minutes.

DRUG

Placebo

Placebo tablets will be brownish-yellow film coated round shape tablets, administered orally. The tablets have to be swallowed completely with 240 milliliters of water, without chewing over a period of five minutes.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-04-12
Primary Completion
2008-08-22
Completion
2008-08-22

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00664365 on ClinicalTrials.gov