Radiolabel Study In Healthy Volunteers For Insomnia-Targeting Drug

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00520663
First received: August 23, 2007
Last updated: May 31, 2012
Last verified: February 2011
  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
Sleep Initiation and Maintenance Disorders
Insomnia
Drug: 14C-SB649868
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
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

Resource links provided by NLM:


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)
Intervention Details:
    Drug: 14C-SB649868
    Other Name: 14C-SB649868
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00520663     History of Changes
Other Study ID Numbers: OXS109139
Study First Received: August 23, 2007
Last Updated: May 31, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on October 23, 2014