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FTIH Study With GSK958108 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

FTIH Study With GSK958108

A Single Blind, Randomised, Placebo Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK958108 in Healthy Male Subjects

NCT00664365•GlaxoSmithKline

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 65 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
•Male between 18 and 65 years of age
•Male subjects must agree to use one of the contraception methods as per protocol. This criterion must be followed from the time of the first dose of study medication until 3 months after last dose.
•Body weight \> 50 kg (110 lbs) for men and BMI within the range 19.0 - 29.9 kg/m2 inclusive)
•Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
•The subject has a visual acuity that is equivalent to 20/20 in each eye, with appropriate correction if needed
•The subject is able to cooperate in all part of the eye examination (including dilation with mydriatics)

Exclusion Criteria

•The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines (Can be repeated once at screening).
•A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening (with the exception of phase I hepatic impairment studies, oncology studies, hepatitis, hepatic fibrosis, or HIV studies).
•A positive test for HIV antibody.
•History of long QT syndrome (personal or family) or other cardiac conduction disorder, or other clinically significant cardiac disease.
•The subject has prolactin, total and free testosterone, LH, FSH outside of the normal range (to be discussed with the Medical Monitor, if necessary).
•History of regular alcohol consumption within 6 months of the study defined as:
•\- an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males). One unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
•The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
•Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
•Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
+9 more criteria

Locations (1)

GSK Investigational Site

London, United Kingdom

Key Dates

Start Date

April 12, 2008

Primary Completion Date

August 22, 2008

Completion Date

August 22, 2008

Last Updated

August 1, 2017

Enrollment

ACTUAL participants

Conditions

Premature Ejaculation

Interventions

GSK958108

DRUG

Placebo

DRUG

Study to Evaluate the Potential Effects of KH-001 on Intravaginal Ejaculatory Latency Time (IELT), Patient-Reported Outcomes, and Safety in Men With Lifelong Premature Ejaculation (LPE)

NCT07434271

Premature Ejaculation

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RECRUITINGNA

Brain Activity During Sexual Behavior in Patients With Primary Premature Ejaculation a Clinical Trial

NCT06570135

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NOT_YET_RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 1, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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FTIH Study With GSK958108

Inclusion Criteria

Exclusion Criteria

Study to Evaluate the Potential Effects of KH-001 on Intravaginal Ejaculatory Latency Time (IELT), Patient-Reported Outcomes, and Safety in Men With Lifelong Premature Ejaculation (LPE)

Brain Activity During Sexual Behavior in Patients With Primary Premature Ejaculation a Clinical Trial

Hyaluronic Acid vs Botulinum Toxin Injection in Treatment of Lifelong Drug-Resistant Premature Ejaculation: Randomized Study

THE IMPACT OF VITAMIN B12 TREATMENT ON EJACULATORY FUNCTIONS IN MEN: SYMPTOMATIC RELIEF AND IMPROVED OUTCOMES

Primary Premature Ejaculation Genetics

Clinical Study to Reduce Premature Ejaculation in Healthy Adult Men