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Radiolabel Study In Healthy Volunteers For Insomnia-Targeting Drug | Clinical Trials | Clareo Health

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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

NCT00520663•GlaxoSmithKline

View on ClinicalTrials.gov

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.

Eligibility

Age

30 - 55 years

Sex

MALE

Healthy Volunteers

Yes

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.
+3 more criteria

Locations (1)

GSK Investigational Site

Tranent, West Lothian, United Kingdom

Key Dates

Start Date

June 8, 2007

Primary Completion Date

August 10, 2007

Completion Date

August 10, 2007

Last Updated

August 2, 2017

Enrollment

ACTUAL participants

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

14C-SB649868

DRUG

Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress

NCT03642028

Sleep Initiation and Maintenance DisordersStress Disorders, Posttraumatic

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RECRUITINGNA

Optimizing Sleep Health in Nurses

NCT05965609

Circadian Rhythm Sleep-Wake Disorders, Shift Work TypeSleep Initiation and Maintenance Disorders

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 2, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Radiolabel Study In Healthy Volunteers For Insomnia-Targeting Drug

Inclusion Criteria

Exclusion Criteria

Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress

Optimizing Sleep Health in Nurses

Evaluation of the Effectiveness of Patient Therapeutic Education on Chronic Insomnia

Sleep Healthy Using the Internet Mitigating Insomnia to Address Neurocognitive Difficulties (SHUTi MIND)

Sensory-Friendly Physical Activity for Sleep in Autistic Children

Remote Guided Caffeine Reduction