Back to resultsRadiolabel Study In Healthy Volunteers For Insomnia-Targeting Drug
Primary Purpose
Sleep Initiation and Maintenance Disorders
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
14C-SB649868
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders focused on measuring Distribution,, SB-649868,, Healthy,, Excretion,, Sleep disturbances, Volunteer,, Metabolism,, Absorption,
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.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Healthy male subjects
Arm Description
Each subject will receive a single oral dose of 14C-SB649868 (containing approximately 70 microcuries of radiocarbon and 30 milligrams of SB649868).
Outcomes
Primary Outcome Measures
Excretion of SB649868 by measuring radioactivity in urine and faeces
Plasma levels of SB-649868 by measuring drug levels and radioactivity in plasma. Plasma, urine,faeces samples to study the metabolites of SB649868.
Secondary Outcome Measures
Safety and tolerability of 14C-SB649868 by adverse event monitoring, lab samples and cardiovascular monitoring.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00520663
Brief Title
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
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 8, 2007 (Actual)
Primary Completion Date
August 10, 2007 (Actual)
Study Completion Date
August 10, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders
Keywords
Distribution,, SB-649868,, Healthy,, Excretion,, Sleep disturbances, Volunteer,, Metabolism,, Absorption,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy male subjects
Arm Type
Experimental
Arm Description
Each subject will receive a single oral dose of 14C-SB649868 (containing approximately 70 microcuries of radiocarbon and 30 milligrams of SB649868).
Intervention Type
Drug
Intervention Name(s)
14C-SB649868
Intervention Description
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.
Primary Outcome Measure Information:
Title
Excretion of SB649868 by measuring radioactivity in urine and faeces
Time Frame
over 7-10 days.
Title
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 Measure Information:
Title
Safety and tolerability of 14C-SB649868 by adverse event monitoring, lab samples and cardiovascular monitoring.
Time Frame
over the course of the study
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Tranent
State/Province
West Lothian
ZIP/Postal Code
EH33 2NE
Country
United Kingdom
12. IPD Sharing Statement
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Radiolabel Study In Healthy Volunteers For Insomnia-Targeting Drug
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