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Radiolabel Study In Healthy Volunteers For Insomnia-Targeting Drug
This study has been completed.
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00520663
  Purpose

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
Insomnia
Drug: 14C-SB649868
Phase I

MedlinePlus related topics: Urine and Urination
U.S. FDA Resources
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

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)
  Eligibility

Ages Eligible for Study:   30 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00520663

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

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

Keywords provided by GlaxoSmithKline:
SB-649868,
Absorption,
Distribution,
Metabolism,
Excretion,
Healthy,
Volunteer,
Sleep disturbances

Study placed in the following topic categories:
Dyssomnias
Sleep Disorders
Healthy

ClinicalTrials.gov processed this record on January 16, 2009