Radiolabel Study In Healthy Volunteers For Insomnia-Targeting Drug

NCT00520663 | Completed Phase 1

• 1 other identifier: OXS109139
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

Distribution,; SB-649868,; Healthy,; Excretion,; Sleep disturbances; Volunteer,; Metabolism,; Absorption,

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Safety and tolerability of 14C-SB649868 by adverse event monitoring, lab samples and cardiovascular monitoring.

  over the course of the study

Study Arms (1)

Healthy male subjects

EXPERIMENTAL

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

Interventions

14C-SB649868 DRUG

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.

Healthy male subjects

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Tranent, West Lothian, EH33 2NE, United Kingdom

Location

Related Links

• Results for study 109139 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Parasomnias

Interventions

N-((1-((5-(4-fluorophenyl)-2-methyl-4-thiazolyl)carbonyl)-2-piperidinyl)methyl)-4-benzofurancarboxamide

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2007
• First Posted: August 24, 2007
• Study Start: June 8, 2007
• Primary Completion: August 10, 2007
• Study Completion: August 10, 2007
• Last Updated: August 2, 2017

Record last verified: 2017-08

Locations

GB (1)