Sleep Initiation and Maintenance Disorders
Conditions
Keywords
Distribution,, SB-649868,, Healthy,, Excretion,, Sleep disturbances, Volunteer,, Metabolism,, Absorption,
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.
Interventions
DRUG14C-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.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Excretion of SB649868 by measuring radioactivity in urine and faeces | over 7-10 days. |
| Plasma levels of SB-649868 by measuring drug levels and radioactivity in plasma. Plasma, urine,faeces samples to study the metabolites of SB649868. | over 4 days |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability of 14C-SB649868 by adverse event monitoring, lab samples and cardiovascular monitoring. | over the course of the study |
Countries
United Kingdom
Outcome results
None listed