Radiolabel Study In Healthy Volunteers For Insomnia-Targeting Drug

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 1

Conditions

Sleep Initiation and Maintenance Disorders

Treatments

Drug: 14C-SB649868

Study type

Interventional

Funder types

Industry

Identifiers

NCT00520663

OXS109139

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

Male

Ages

30 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.