Radiolabel Study In Healthy Volunteers For Insomnia-Targeting Drug
Phase 1
Completed
- Conditions
- Sleep Initiation and Maintenance Disorders
- Interventions
- Drug: 14C-SB649868
- Registration Number
- NCT00520663
- Lead Sponsor
- GlaxoSmithKline
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 8
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Healthy male subjects 14C-SB649868 Each subject will receive a single oral dose of 14C-SB649868 (containing approximately 70 microcuries of radiocarbon and 30 milligrams of SB649868).
- Primary Outcome Measures
Name Time Method 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 Excretion of SB649868 by measuring radioactivity in urine and faeces over 7-10 days.
- Secondary Outcome Measures
Name Time Method Safety and tolerability of 14C-SB649868 by adverse event monitoring, lab samples and cardiovascular monitoring. over the course of the study
Trial Locations
- Locations (1)
GSK Investigational Site
🇬🇧Tranent, West Lothian, United Kingdom