Radiolabel Study In Healthy Volunteers For Insomnia-Targeting Drug

An Open-label Study to Determine the Excretion, Balance and Pharmacokinetics of SB649868 After a Single Oral Administration of 14C-SB649868 in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Sleep Initiation and Maintenance Disorders
• Intervention / Treatment: Drug: 14C-SB649868

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • West Lothian
    • Tranent, West Lothian, United Kingdom, EH33 2NE
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Excretion of SB649868 by measuring radioactivity in urine and faeces	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.	over 4 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability of 14C-SB649868 by adverse event monitoring, lab samples and cardiovascular monitoring.	over the course of the study

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2007
• Primary Completion (Actual): August 10, 2007
• Study Completion (Actual): August 10, 2007

Study Registration Dates

• First Submitted: August 23, 2007
• First Submitted That Met QC Criteria: August 23, 2007
• First Posted (Estimate): August 24, 2007

Study Record Updates

• Last Update Posted (Actual): August 2, 2017
• Last Update Submitted That Met QC Criteria: August 1, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Sleep disturbances; Distribution,; SB-649868,; Healthy,; Excretion,; Volunteer,; Metabolism,; Absorption,
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: OXS109139