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Radiolabel Study In Healthy Volunteers For Insomnia-Targeting Drug

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: August 23, 2007
Last updated: May 31, 2012
Last verified: February 2011
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
Sleep Initiation and Maintenance Disorders
Drug: 14C-SB649868
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Excretion of SB649868 by measuring radioactivity in urine and faeces [ Time Frame: 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. [ Time Frame: over 4 days ]

Secondary Outcome Measures:
  • Safety and tolerability of 14C-SB649868 by adverse event monitoring, lab samples and cardiovascular monitoring. [ Time Frame: over the course of the study ]

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   (Adult)
Sexes Eligible for Study:   Male
Accepts 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00520663

United Kingdom
GSK Investigational Site
Tranent, West Lothian, United Kingdom, EH33 2NE
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00520663     History of Changes
Other Study ID Numbers: OXS109139
Study First Received: August 23, 2007
Last Updated: May 31, 2012

Keywords provided by GlaxoSmithKline:
Sleep disturbances

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders processed this record on April 26, 2017