Clinical trial NCT00520663: Radiolabel Study In Healthy Volunteers For Insomnia-Targeting Drug
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sleep Initiation and Maintenance Disorders
Keywords: Distribution,
SB-649868,
Healthy,
Excretion,
Sleep disturbances
Volunteer,
Metabolism,
Absorption,
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-08-24
Enrollment: 8
Sex: MALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Excretion of SB649868 by measuring radioactivity in urine and faeces
timeFrame: over 7-10 days.
measure: Plasma levels of SB-649868 by measuring drug levels and radioactivity in plasma. Plasma, urine,faeces samples to study the metabolites of SB649868.
timeFrame: over 4 days
Secondary outcomes:
measure: Safety and tolerability of 14C-SB649868 by adverse event monitoring, lab samples and cardiovascular monitoring.
timeFrame: over the course of the study
Other outcomes:
Locations:
city: Tranent
country: United Kingdom
facility: GSK Investigational Site
state: West Lothian
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: