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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00976105 |
Purpose
The overall purpose of this study is to see whether the drug is safe and well tolerated when given to overweight or obese but otherwise healthy volunteers for 10 days. Up to 4 groups of people will be given the drug at variable strengths. The blood levels of the drug will be measured and the effects on mood and cognition (the mental processes involved in awareness, learning and judgement) will be assesed.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity |
Drug: GSK1521498 or placebo Drug: Zolpidem or placebo - Hypnotic drug given for sleep disorders |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study |
| Official Title: | A Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of 10 Days of Repeat Dosing of GSK1521498 in Overweight or Obese But Otherwise Healthy Subjects. |
| Estimated Enrollment: | 64 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | January 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Part A: Zolpidem or placebo: Active Comparator
This part is designed to examine the acute effects of up to 10mg of a known hypnotic sedative drug (Zolpidem) on cognitive and mood changes sensitve to sedation and tiredess.
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Drug: Zolpidem or placebo - Hypnotic drug given for sleep disorders
The information gathered from Part A will be used as a benchmark against which any effects of GSK1521498 can be assessed in Part B.
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Part B: GSK1521498 or placebo: Experimental
At least 15 hours after Part A is completed subjects will enter Part B of the study.
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Drug: GSK1521498 or placebo
The first group will start at a low dose (10 mg GSK1521498 or placebo) for 10 days. The study team will then assess the data gathered from the first cohort and will select the dose that the next cohort will receive for 10 days. There will be up to 4 cohorts.
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This study is to test a new drug which may be used for treating eating behaviour and patterns that some overweight and obese patients find difficult to control. The drug works by inhibiting the effects of messenger molecules called opioids, e.g. endorphins. These opioids are naturally produced within the human body and control hunger, thirst, and the pleasurable feelings we relate to eating food. The drug attaches to opioid binding sites in the brain, known as mu-opioid receptors; this blocks the natural effect of opioids which may reduce the craving to eat fatty or sugary foods. Single doses of the drug have been given to humans and showed it was safe. Now the drug will be given every day for 10 days to check that the drug is safe and tolerated when given repeatedly. The study is in two parts:
Part A: people will receive a sleeping tablet to make them sleepy (or a dummy drug) and will complete some questionnaires and simple tests including computer exercises to test the effect of this tablet on mood and cognition. This information will be used to help judge what is happening in Part B.
Part B: requires staying in the unit for 10 days to receive a tablet every day and complete questionnaires and other tests to check for any mood and cognitive changes. Various other assessments will include effects on eating behaviour, pain measures and changes in body composition (content of fat, muscle and water).
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
| United Kingdom, Cambridgeshire | |
| GSK Investigational Site | Recruiting |
| Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ | |
| Principal Investigator: Annelize Koch | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 111849 |
| Study First Received: | September 11, 2009 |
| Last Updated: | December 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00976105 History of Changes |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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Repeat dose Safety and tolerability Pharmacokinetics Pharmacodynamics |
Healthy volunteers Fat mass Personality traits |
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Body Weight Signs and Symptoms Obesity Therapeutic Uses Physiological Effects of Drugs Hypnotics and Sedatives |
Central Nervous System Depressants Nutrition Disorders Overweight Overnutrition Central Nervous System Agents Pharmacologic Actions |