Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Zolpidem or placebo- Hypnotic drug given for sleep disorders · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 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. |
| Part B: GSK1521498 or placebo | EXPERIMENTAL | At least 15 hours after Part A is completed subjects will enter Part B of the study. |
| Name | Type | Description |
|---|---|---|
| Zolpidem or placebo - Hypnotic drug given for sleep disorders | DRUG | The information gathered from Part A will be used as a benchmark against which any effects of GSK1521498 can be assessed in Part B. |
| GSK1521498 or placebo | DRUG | 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. |
Inclusion Criteria: * Healthy as determined by a responsible and experienced physician * Non smoking male or female between 18 and 60 years of age inclusive * A female subject of child-bearing potential must use a contraception method listed in the protocol prior to the start of dosing until at lea...
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