Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAM-531 and gemfibrozil · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | SAM-531\_gemfibrozil |
| 2 | PLACEBO_COMPARATOR | - |
| 3 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| SAM-531 and gemfibrozil | DRUG | 2 single doses of 5 mg SAM-531 (capsules) a daily dose of 1200 mg Gemfibrozil (one tablet of 600mg at approximately 8 a.m. and one tablet of 600 mg at approximately 6 p.m.) for 14 days |
| SAM-531 | DRUG | dosage form : 0.5 mg and 5 mg capsules 3 different single doses : 1 mg, 3mg and 10 mg of SAM-531 |
| placebo | OTHER | placebo |
| Donepezil | DRUG | dosage form: 5 mg encapsulated tablets one single dose of 5 mg. |
Inclusion Criteria: * Body mass index in the range of 18 to 30 kg/m2 and body weight greater than 50 kg. * Healthy as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12-lead ECG rea...
SAM-531 is an investigational small molecule being studied for Alzheimer Disease. It has been evaluated in healthy volunteers and in patients with Alzheimer Disease across multiple clinical trials. The drug is currently in Phase 2 development and is not approved by the FDA.
SAM-531 is being developed by Pfizer, Inc., a company listed on the New York Stock Exchange under the ticker symbol PFE. Pfizer has sponsored multiple clinical trials of SAM-531 in healthy subjects and in patients with Alzheimer Disease.
SAM-531 is in Phase 2 clinical development. It has completed eight clinical trials, including Phase 1 studies, with a total enrollment of 412 participants. The drug remains investigational and has not received regulatory approval.
SAM-531 has completed eight clinical trials. Notable studies include NCT00479297 in healthy Japanese males, NCT00519298 on sleep EEG in healthy subjects, NCT00745576 on interaction with verapamil, and NCT00966966 on interaction with gemfibrozil. All trials are completed, with no active trials ongoing.
SAM-531 is the primary name used in clinical trial records for this investigational drug. No alternative names have been associated with SAM-531 in the available trial data. It is a distinct small molecule being studied for Alzheimer Disease.
SAM-531 has been studied in randomized, double-blind, active-controlled trials. These trials included both healthy volunteers and patients with Alzheimer Disease, with a focus on safety, tolerability, pharmacokinetics, and pharmacodynamics. The studies were not biomarker-selected.