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...
Top 20 of 36 competitors
Zolpidem or placebo- Hypnotic drug given for sleep disorders is a small molecule hypnotic drug candidate that GSK plc is developing for obesity. It is being studied in a Phase 1 clinical program. The drug is given as a hypnotic for sleep disorders, but its development is focused on obesity as the indication.
Zolpidem or placebo- Hypnotic drug given for sleep disorders is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program for this drug candidate.
Zolpidem or placebo- Hypnotic drug given for sleep disorders is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program includes one completed trial.
Zolpidem or placebo- Hypnotic drug given for sleep disorders has been studied in one completed Phase 1 trial, NCT00976105, titled Effects of Repeat Dosing of GSK1521498. The trial enrolled 49 participants in the United Kingdom and included healthy volunteers.
Yes, Zolpidem or placebo- Hypnotic drug given for sleep disorders is also known as GSK1521498. The alternative name GSK1521498 appears in the trial title for NCT00976105, which studied repeat dosing of the drug.