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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00857883 |
This is a first-time-in-human study. The overall purpose of the study is to assess whether the drug is safe and well tolerated after single, increasing doses. The blood levels of the drug after different doses will be measured and the effect of the drug on pleasurable eating behaviour will be assessed.
Condition | Intervention | Phase |
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Obesity |
Drug: GSK1521498 or placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study |
Official Title: | A First-Time-In-Human, Three-Part, Placebo-Controlled, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK1521498 in Healthy Subjects |
Enrollment: | 56 |
Study Start Date: | November 2008 |
Study Completion Date: | August 2009 |
Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Part B: Active Comparator
Part B: A dose selected from Part A that was well tolerated will be used to check if there is a difference in the pharmacokinetics (blood levels) of the study drug when taken without food in liquid form, or as a capsule, or as a capsule together with a high fat meal to assess the effect of food. One group of 12 healthy male or female volunteers will be enrolled.
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Drug: GSK1521498 or placebo
GSK1521498 is a mu-opioid receptor inverse agonist
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Part C: Placebo Comparator
Part C: A well tolerated dose selected from Parts A & B will be used to test whether the drug has an effect on individual preferences for sugary and high fat food, when compared to placebo. Up to 32 healthy overweight male volunteers will be enrolled.
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Drug: GSK1521498 or placebo
GSK1521498 is a mu-opioid receptor inverse agonist
|
Part A: Placebo Comparator
Part A: This part of the study will start with a very low dose of study drug, which will then be gradually increased in subsequent doses. This is known as dose-rising and is the way to assess safety and tolerability (i.e. possible presence of any side effects that make taking the drug unpleasant) of increasing doses of the study drug. Effects will be compared to those seen when a placebo is taken. Up to 4 groups of 6-9 healthy male or female volunteers will be enrolled.
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Drug: GSK1521498 or placebo
GSK1521498 is a mu-opioid receptor inverse agonist
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The human body naturally produces substances known as opioids and the pleasurable (or hedonic) response to eating highly sugary or fatty foods is increased by opioids. The drug to be tested in this study attaches to specific binding sites in the brain, known as mu-opioid receptors. This may stop the natural effect of opioids and therefore reduce the pleasurable response to food. We predict that this in turn may help patients with obesity to lose weight more effectively. The study is divided into three parts: Part A: This part of the study will start with a very low dose of study drug, which will then be gradually increased in subesquent doses. This is known as dose-rising and is the way to assess safety and tolerability (any side effects that make taking the drug unpleasant). Effects will be compared to those seen when a placebo (a "dummy" drug) is taken. Up to 4 groups of 6-9 healthy male or female volunteers will be enrolled in this part of the study. Part B: A dose selected from Part A that was well tolerated will be used to check if there is a difference in the blood levels of the study drug when taken without food in liquid form, without food as a capsule, or with a high fat meal as a capsule. One group of 12 healthy male or female volunteers will be enrolled in this part of the study. Part C: A well tolerated dose selected from Parts A & B will be used to test whether the drug has an effect on preferences for sugary and high fat food, when compared to placebo. Up to 32 healthy overweight male volunteers will be enrolled in this part of the study.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom, Cambridgeshire | |
GSK Investigational Site | |
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 111314 |
Study First Received: | February 24, 2009 |
Last Updated: | August 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00857883 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
First-Time-In-Humans Pharmacokinetics Pharmacodynamics Food Effect |
Binge Eating Obesity Healthy Volunteers |
Body Weight Signs and Symptoms Obesity Bulimia |
Nutrition Disorders Overweight Overnutrition Healthy |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |