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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00520663 |
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.
Condition | Intervention | Phase |
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Insomnia |
Drug: 14C-SB649868 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study |
Official Title: | An Open-Label Study to Determine the Excretion, Balance and Pharmacokinetics of SB649868 After a Single Oral Administration of 14C-SB649868 in Healthy Volunteers |
Enrollment: | 8 |
Study Start Date: | June 2007 |
Study Completion Date: | August 2007 |
Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 30 Years to 55 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
LH, FSH and testosterone hormones must be within normal reference range.
Exclusion criteria:
United Kingdom, West Lothian | |
GSK Investigational Site | |
Tranent, West Lothian, United Kingdom, EH33 2NE |
Study Director: | GSK Clinical Trials, M.D. | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | OXS109139 |
Study First Received: | August 23, 2007 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00520663 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
SB-649868, Absorption, Distribution, Metabolism, |
Excretion, Healthy, Volunteer, Sleep disturbances |
Dyssomnias Sleep Disorders Healthy |