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Also known as PF-05212377, PF-05212377 (SAM-760)
SAM-760 · 5 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| PF-05212377 70 mg | EXPERIMENTAL | - |
| PF-05212377 20 mg | EXPERIMENTAL | - |
| PF-05212377 10 mg | EXPERIMENTAL | - |
| Placebo | EXPERIMENTAL | placebo, plus scopolamine 0.5 mg |
| PF-05212377 5 mg, plus scopolamine 0.5 mg; | EXPERIMENTAL | - |
| PF-05212377 20 mg, plus scopolamine 0.5 mg; | EXPERIMENTAL | - |
| PF-05212377 60 mg, plus scopolamine 0.5 mg; | EXPERIMENTAL | - |
| donepezil 10 mg, plus scopolamine 0.5 mg. | ACTIVE_COMPARATOR | - |
| PF-05212377 | EXPERIMENTAL | - |
| Active | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | active arm/healthy young |
| 2 | PLACEBO_COMPARATOR | placebo arm |
| 3 | OTHER | ketoconazole interaction evaluation |
| Name | Type | Description |
|---|---|---|
| PF-05212377 | DRUG | Single, oral dose administration of 70 mg PF-0521377 using a capsule formulation. |
| Placebo | DRUG | Capsule, single dose, oral, 1 day |
| Scopolamine | DRUG | injectable subcutaneous formulation, single dose, 1 day |
| Donepezil | DRUG | Tablet, 10mg, single dose, 1 day |
| PF-05212377 (SAM-760) | DRUG | Oral capsule, once daily for 14 days 1.5 mg, 5 mg, 15 mg, 30 mg and 50 mg |
| SAM-760 | DRUG | SAM-760 capsule, 0.25, 0.75, 2.25, 5, 10, 15, 20, 25, 35 and 45mg, single dose, 1 day |
| Placebo of SAM-760 | DRUG | SAM-760 matching placebo capsule, single dose, 1 day, |
| ketoconazole | DRUG | Ketoconazole oral tablets, 200 mg bid, 14 days |
Inclusion Criteria: * Males and females must be at least 18 years of age and no older than 55 years of age with a Body Mass Index (BMI) must be between 17.5 and 30.5. * Subjects must sign a consent form and comply with all scheduled visits, treatment plan, lab tests and other study procedures. Exc...
SAM-760 is an investigational small molecule developed by Pfizer, Inc. (ticker PFE). It has been studied in a Phase 1 clinical trial involving healthy adult volunteers. The specific disease or condition SAM-760 is intended to treat has not been disclosed, and the compound remains in early clinical development.
SAM-760 is made by Pfizer, Inc., which trades under the ticker symbol PFE. Pfizer is the developer of record for the compound and sponsored the clinical study conducted to evaluate it. No other developer or partner is identified for SAM-760.
SAM-760 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The completed study enrolled 124 healthy volunteers and evaluated single oral doses of SAM-760. SAM-760 is investigational and has not been approved by the FDA.
SAM-760 has been studied in one completed Phase 1 trial, NCT00948662, titled Study Evaluating The Safety And Tolerability Of Administration Of Single Oral Doses Of SAM-760 To Healthy Subjects. The trial enrolled 124 healthy adults in France, was randomized, double blind, and placebo controlled, and included both male and female participants aged 18 years and older.
The SAM-760 Phase 1 trial NCT00948662 was a randomized, double blind, placebo controlled study of single oral doses in healthy volunteers. It enrolled 124 participants of all sexes, aged 18 years and older, at sites in France. The study is listed as completed and did not use biomarker-based patient selection.