Last updated: 06/12/2020 07:55:52
Radiolabel Study In Healthy Volunteers For Insomnia-Targeting Drug
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Excretion of SB649868 by measuring radioactivity in urine and faeces
Timeframe: 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.
Timeframe: over 4 days
Secondary outcomes:
Safety and tolerability of 14C-SB649868 by adverse event monitoring, lab samples and cardiovascular monitoring.
Timeframe: over the course of the study
Interventions:
Drug: 14C-SB649868
Enrollment:
8
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Sleep Initiation and Maintenance Disorders
Product
SB649868
Collaborators
Not applicable
Study date(s)
June 2007 to August 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
30 - 55 years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Tranent, West Lothian, United Kingdom, EH33 2NE
Status
Will Be Recruiting
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-10-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Results for study 109139 can be found on the GSK Clinical Study Register.
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