Radiolabel Study In Healthy Volunteers For Insomnia-Targeting Drug

NCT ID: NCT00520663

Last Updated: 2017-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-08
• Study Completion Date: 2007-08-10

Brief Summary

The purpose of this study is to define the absorption, breakdown and excretion of a single dose of radiolabelled SB-649868 and its breakdown products by measuring their concentration in blood, urine and faeces over a 7-10 day period. "Radiolabelled" means that the test drug has a radioactive component to help us track the drug. The safety and tolerability of the test drug will also be assessed.

Conditions

Sleep Initiation and Maintenance Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Healthy male subjects

Each subject will receive a single oral dose of 14C-SB649868 (containing approximately 70 microcuries of radiocarbon and 30 milligrams of SB649868).

Group Type: EXPERIMENTAL

14C-SB649868

Intervention Type: DRUG

SB-649868 will be provided as powder in a bottle which will be reconstituted into a solution prior to dosing via a hard gelatin capsule. Each subject will receive one unit dose of SB-649868 30 milligram reconstituted powder presented in a size 00 capsule once. The capsule will be swallowed with 160 milliliters of water.

Interventions

14C-SB649868

SB-649868 will be provided as powder in a bottle which will be reconstituted into a solution prior to dosing via a hard gelatin capsule. Each subject will receive one unit dose of SB-649868 30 milligram reconstituted powder presented in a size 00 capsule once. The capsule will be swallowed with 160 milliliters of water.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy males, aged 30-55 years inclusive.
• Body weight more or equal to 50kg with a BMI (body mass index) between 18.5-29.9kg/m2 inclusive.
• Healthy as based on a medical evaluation consisting of medical history, physical examination, lab tests on blood and urine and cardiovascular monitoring.

LH, FSH and testosterone hormones must be within normal reference range.

Exclusion Criteria

• Positive urine drug screen or alcohol breath test at screening visit.
• Average weekly alcohol intake of more than 21 units or average daily intake of more than 3 units.
• Grapefruit or grapefruit juice intake 7 days before dosing and until the last blood sample is taken.
• Any subject who is not prepared to eat standard meals in the clinic or is a vegetarian.
• Participated in a clinical trial for a new drug within 30 days or 5 half-lives or twice the duration of that drugs effect before the dosing day for this study.
• Exposure to 4 new drugs in clinical trials within the last 12 months before dosing in this study.
• Use of any medications (prescribed or non-prescribed including vitamins and herbal supplements) within 7 days before dosing in this study.
• Participation in this study would result in the subject donating more than 500ml in a 56 day period.
• Regular use of tobacco or nicotine-containing products within 6 months of screening.
• Unwillingness to abstain from sexual intercourse with pregnant or lactating women from dosing until 84 days after.
• Unwillingness to use contraception and have female partner use contraception if she could become pregnant for 84 days after dosing.
• Unwillingness to abstain from strenuous physical activity for 48 hours before screening and in the 72 hours before and 48 hours after the treatment period.
• Administration of radiolabelled substances or exposure to significant radiation (eg serial X-rays or CT scans, barium meal etc)within the past 12 months from screening.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Tranent, West Lothian, United Kingdom

Countries

United Kingdom

Other Identifiers

OXS109139

Identifier Type: -

Identifier Source: org_study_id