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Also known as BMS-708163 (Gamma-Secretase Inhibitor), (GAMMA SECRETASE inhibitor), Avagacestat
BMS-708163 · 10 trials · 3 indications
Based on adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests
| Arm | Type | Description |
|---|---|---|
| A1 | ACTIVE_COMPARATOR | - |
| A2 | ACTIVE_COMPARATOR | - |
| A3 | ACTIVE_COMPARATOR | - |
| A4 | ACTIVE_COMPARATOR | - |
| A5 | PLACEBO_COMPARATOR | - |
| BMS-708163 | EXPERIMENTAL | - |
| Rifampin | OTHER | - |
| Rifampin + BMS-708163 | EXPERIMENTAL | - |
| A1 (BMS-708163) | ACTIVE_COMPARATOR | - |
| A2 (Placebo) | PLACEBO_COMPARATOR | - |
| B1 (BMS-708163) | ACTIVE_COMPARATOR | - |
| B2 (Placebo) | PLACEBO_COMPARATOR | - |
| galantamine 8 mg (ER) | ACTIVE_COMPARATOR | - |
| galantamine 16 mg (ER) | ACTIVE_COMPARATOR | - |
| Donepezil and BMS-708163 | EXPERIMENTAL | - |
| BMS-708163 (800 mg) | EXPERIMENTAL | - |
| BMS-708163 (200 mg) | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Moxifloxacin | ACTIVE_COMPARATOR | - |
| Treatment A (Reference) | EXPERIMENTAL | - |
| Treatment B | ACTIVE_COMPARATOR | - |
| Treatment C | ACTIVE_COMPARATOR | - |
| Treatment D | ACTIVE_COMPARATOR | - |
| Treatment E | ACTIVE_COMPARATOR | - |
| BMS-708163 / Ketoconazole | ACTIVE_COMPARATOR | - |
| BMS-708163 / Fluconazole | ACTIVE_COMPARATOR | - |
| Panel 1: BMS-708163 or Placebo | EXPERIMENTAL | Healthy male subjects (age: 18 to 45 years) |
| Panel 2: BMS-708163 or Placebo | EXPERIMENTAL | Healthy male subjects (age: 18 to 45 years) |
| Panel 3: BMS-708163 or Placebo | EXPERIMENTAL | Healthy male subjects (age: 18 to 45 years) |
| Panel 4: BMS-708163 or Placebo | EXPERIMENTAL | Healthy male subjects (age: 18 to 45 years) |
| Panel 5: BMS-708163 or Placebo | EXPERIMENTAL | Healthy male subjects (age: 18 to 45 years). In Period 2: Subjects will receive BMS-708163 or placebo as a capsule formulation. In Period 3: Subjects will receive BMS-708163 or placebo as a capsule formulation within 5 minutes of consuming a standard high-fat breakfast on Day 1 |
| Panel 6: BMS-708163 or Placebo | EXPERIMENTAL | Healthy male subjects (age: 18 to 45 years) |
| Panel 7: BMS-708163 or Placebo | EXPERIMENTAL | Healthy male subjects (age: 18 to 45 years) |
| Panel 8: BMS-708163 or Placebo | EXPERIMENTAL | Healthy male subjects (age: 18 to 45 years) |
| Panel 9: BMS-708163 or Placebo | EXPERIMENTAL | Healthy, elderly male subjects (age: 60 years and greater) |
| Panel 10: BMS-708163 or Placebo | EXPERIMENTAL | Healthy, elderly female subjects (age: 60 years and greater) |
| Panel 11: BMS-708163 or Placebo | EXPERIMENTAL | Healthy male subjects (age: between 46 to 59 years) |
| Panel 12: BMS-708163 or Placebo | EXPERIMENTAL | Healthy male and/or female subjects or subjects with MCI (age: between 60-74 years) |
| Panel 13: BMS-708163 or Placebo | EXPERIMENTAL | Healthy male and/or female subjects or with AD or MCI (age: 75 years or greater) |
| Panel 15: BMS-708163 or Placebo | EXPERIMENTAL | Healthy young male subjects |
| Name | Type | Description |
|---|---|---|
| BMS-708163 | DRUG | Capsules, Oral, 25 mg, once daily, 24 weeks |
| Placebo | DRUG | Capsules, Oral, 0 mg, once daily, 24 weeks |
| Rifampin | DRUG | Capsule, Oral, 600 mg, Once daily, 7 days |
| galantamine | DRUG | Capsule, Oral, 8 mg (ER), once daily, Days 1-7 |
| Donepezil | DRUG | Tablets, Oral, 5 mg, Once Daily, Days 1-28 |
| Moxifloxacin | DRUG | Tablets, Oral, 400 mg, Once on Day 1, approximately 14 days |
| BMS-708163 + Ketoconazole | DRUG | (BMS-708163) - Capsule, Oral, 50 mg, daily, 1 day Day 12 (Ketoconazole) - Tablet, Oral, 400 mg, daily, 1 day |
| Ketoconazole | DRUG | Tablet, Oral, 400 mg, daily, 16 days |
| Fluconazole | DRUG | Tablet, Oral, 1 day 400 mg then 3 days 200 mg |
| BMS-708163 + Fluconazole | DRUG | (BMS-708163) - Capsule, Oral, 50 mg, daily, 1 day (Day 12) (Fluconazole) - Tablet, Oral, 200 mg, daily, 13 days |
| BMS-708163 (Gamma-Secretase Inhibitor) | DRUG | Oral Solution, Oral, 0.3 mg, Once daily, once |
| Placebo matching BMS-708163 | DRUG | Oral Solution, Oral, 0 mg, Once daily, once |
Inclusion Criteria: * Clinical diagnosis of Mild to Moderate Alzheimer's disease (MMSE 16-26) * 6 Month cognitive decline * Stable marketed AD therapy x2 months or additional marketed AD therapy during study * Score of \<=4 on the Modified Hachinski Ischemia Scale * CT results consistent with Alzhe...
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BMS-708163 is an investigational small molecule developed by Bristol-Myers Squibb for Alzheimer disease. It is also known as a gamma-secretase inhibitor. It has been studied in Phase 2 clinical development and has not been approved by the FDA. All ten of its registered trials are completed, with no active trials ongoing.
BMS-708163 was studied as a treatment for Alzheimer disease. It is an investigational agent and is not approved for any indication. Clinical development reached Phase 2, and the program's ten registered trials, which enrolled 563 participants in total, are all completed with no active studies remaining.
BMS-708163 is made by Bristol-Myers Squibb Company, which trades under the ticker BMY. Bristol-Myers Squibb developed the compound as a small molecule gamma-secretase inhibitor for Alzheimer disease and sponsored its clinical trial program, which reached Phase 2 before all studies were completed.
BMS-708163 reached Phase 2 clinical development for Alzheimer disease. It is investigational and has not been approved by the FDA. The program includes ten completed trials with no active trials, and the studies were randomized, double-blind, and placebo-controlled, enrolling 563 participants in total.
BMS-708163 has ten completed clinical trials, including NCT01454115, a Phase 1 safety, pharmacokinetics, and tolerability study in 116 healthy volunteers; NCT01079819, a Phase 1 pharmacokinetics study in 32 participants; NCT01057030, a Phase 1 multiple-dose Japanese bridging study in 22 healthy male volunteers; and NCT01042314, a Phase 1 drug-drug interaction study with donepezil in 18 participants.
BMS-708163 is a gamma-secretase inhibitor, and that description is sometimes used as an alternative name for the compound. It is a small molecule developed by Bristol-Myers Squibb for Alzheimer disease. The drug reached Phase 2 development, and all ten of its registered trials are completed.