Approval Probability
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Adjusted LOA
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GSK1521498 · 3 trials · 2 indications
To test that the OPRM1 A118G polymorphism modulates the effects of GSK1521498 10 mg on brain reward function and processing
Number of subjects with any adverse events during the treatment periods
Systolic and diastolic BP will be measured
12-lead electrocardiograph (ECG) will be measured
Hematology/Chemistry assessments to be done at screening (fasted) and day 5 for each treatment session (un-fasted).
Mood anxiety will be assessed by The Beck Anxiety Inventory (BAI), The Beck Depression Inventory (BDI-II).
Suicidality will be assessed by C-SSRS.
Mood anxiety and suicidality will be assessed by VAS.
CANTAB attention tasks comprising of Simple Reaction Time (SRT), Choice Reaction Time (CRT) and Rapid Visual Information Processing (RVP) will be done to measure the power of attention
AUC and Cmax of GSK1521498 and alcohol
| Arm | Type | Description |
|---|---|---|
| 2 mg GSK1521498 | EXPERIMENTAL | Approximately 20 subjects will be randomised to receive 2 mg GSK1521498. The drug is being developed for the treatment of obesity due to excessive consumption of high calorie foods |
| 5 mg GSK1521498 | EXPERIMENTAL | Approximately 20 subjects will be randomised to receive 5 mg GSK1521498. The drug is being developed for the treatment of obesity due to excessive consumption of high calorie foods |
| Placebo | PLACEBO_COMPARATOR | Approximately 20 subjects will be randomised to receive matching placebo. |
| Treatment A | PLACEBO_COMPARATOR | Subject will receive oral dose of matching placebo once daily for 5 days in one of the 3 treatment periods. |
| Treatment B | EXPERIMENTAL | Subject will receive 25 mg orally once daily for the first two days and 50 mg once daily for 3 days in one of the 3 treatment periods. |
| Treatment C | EXPERIMENTAL | Subject will receive 10 mg orally once daily for 5 days in one of the 3 treatment periods. |
| GSK1521498 & alcohol | EXPERIMENTAL | GSK1521498 20 mg and alcohol (0.5g/kg ethanol mixed with orange juice) |
| GSK1521498 & orange juice | EXPERIMENTAL | GSK1521498 20 mg and orange juice approximately matching alcoholic beverage for volume and colour |
| Placebo & alcohol | EXPERIMENTAL | Placebo and alcohol (0.5g/kg ethanol mixed with orange juice) |
| Placebo & orange juice | PLACEBO_COMPARATOR | Placebo and orange juice approximately matching alcoholic beverage for volume and colour |
| Name | Type | Description |
|---|---|---|
| GSK1521498 | DRUG | GSK1521498 2mg or 5mg will be given for up to 35 days and subjects will be assessed weekly |
| Placebo | DRUG | Placebo will be given for up to 35 days and subjects will be assessed weekly |
| Naltrexone (NTX) | DRUG | Swedish orange gelatin capsule containing 25mg of NTX or 50mg of NTX |
Inclusion Criteria: * Obese but essentially healthy male or female between 18 and 60 years of age inclusive. * Body Mass Index greater than or equal to 30 kg/m2. * Binge Eating Scale (BES) score that is greater than or equal to 19 at screening assessment. * A female subject of child-bearing potenti...
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GSK1521498 is an investigational small molecule being studied for alcoholism and obesity. It is in Phase 1 clinical development and has not been approved by the FDA. The drug is being developed by GSK plc.
GSK1521498 targets the mu opioid receptor, as indicated by a clinical trial evaluating the influence of the A118G polymorphism in the mu opioid receptor gene (OPRM1) on its effects. This suggests the drug works by interacting with this receptor.
GSK1521498 is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is currently in Phase 1 clinical trials for alcoholism and obesity.
GSK1521498 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed for both alcoholism and obesity indications.
GSK1521498 has been studied in clinical trials including NCT01195792 for obesity, NCT01366573 for alcoholism, and NCT01738867 for alcoholism in healthy social drinkers. All trials are completed, with the obesity trial being Phase 2 and the others Phase 1.
No, GSK1521498 is not the same as naltrexone. However, a clinical trial (NCT01738867) compared the effects of GSK1521498 and naltrexone on brain function in healthy social drinkers, indicating they are distinct drugs being studied for similar conditions.