FTIH Study With GSK958108

NCT00664365 | Completed Phase 1

• 1 other identifier: SPE111154
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Premature ejaculation.; FTIH,; GSK958108,; 5HT1a antagonist,

Outcome Measures

Primary Outcomes (1)

• Safety will be evaluated by adverse event monitoring, physical and neurological examination, pupil size, Eye assessment; 12-lead ECG, vital signs and laboratory parameters. These assessments will be conducted at several timepoints after each dosing.

  Up to Day 19

Secondary Outcomes (1)

• To assess the food effect on the pharmacokinetics of GSK958108 in healthy male volunteers

  Up to Day 5

Study Arms (2)

Subjects receiving GSK958108 + placebo in cohort 1

EXPERIMENTAL

Eligible subjects will receive GSK958108 with a starting dose of 1 milligram. The dose escalation will be continued up to 4 ascending doses. Subjects will also receive placebo. Each treatment period will be separated by at least 7 days washout period.

Drug: GSK958108; Drug: Placebo

Subjects receiving GSK958108 + placebo in cohort 2

EXPERIMENTAL

Eligible subjects will start dosing once the cohort 1 has completed the treatment phase and the initial dose will be the same as top dose in Cohort1.The dose escalation will be continued up to 4 ascending doses. Subjects will also receive placebo. Each treatment period will be separated by at least 7 days washout period.

Drug: GSK958108; Drug: Placebo

Interventions

GSK958108 DRUG

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.

Subjects receiving GSK958108 + placebo in cohort 1; Subjects receiving GSK958108 + placebo in cohort 2

Placebo DRUG

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.

Subjects receiving GSK958108 + placebo in cohort 1; Subjects receiving GSK958108 + placebo in cohort 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• History of sensitivity or intolerance to drugs that effect serotonin, including serotonin-reuptake inhibitors (SSRIs),or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
• Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
• The subject has a history of migraine.
• The subject has a history of psychiatric illness.
• Any history of suicidal attempts or behaviour.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

London, NW10 7NS, United Kingdom

Location

Related Links

• Results for study SPE111154 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Premature Ejaculation

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2008
• First Posted: April 22, 2008
• Study Start: April 12, 2008
• Primary Completion: August 22, 2008
• Study Completion: August 22, 2008
• Last Updated: August 1, 2017

Record last verified: 2017-07

Locations

GB (1)