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Radiolabel Study In Healthy Volunteers For Insomnia-Targeting Drug

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00520663
First Posted: August 24, 2007
Last Update Posted: August 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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 Drug: 14C-SB649868 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date: June 8, 2007
Study Completion Date: August 10, 2007
Primary Completion Date: August 10, 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Healthy male subjects
Each subject will receive a single oral dose of 14C-SB649868 (containing approximately 70 microcuries of radiocarbon and 30 milligrams of SB649868).
Drug: 14C-SB649868
SB-649868 will be provided as powder in a bottle which will be reconstituted into a solution prior to dosing via a hard gelatin capsule. Each subject will receive one unit dose of SB-649868 30 milligram reconstituted powder presented in a size 00 capsule once. The capsule will be swallowed with 160 milliliters of water.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00520663     History of Changes
Other Study ID Numbers: OXS109139
First Submitted: August 23, 2007
First Posted: August 24, 2007
Last Update Posted: August 2, 2017
Last Verified: August 2017

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

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders