Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 | - |
| 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 | - |
| BMS-708163 - Panel 1 | EXPERIMENTAL | (Age 20-45 years) |
| BMS-708163 - Panel 2 | EXPERIMENTAL | (Age 20-45 years) |
| BMS-708163 - Panel 3 | EXPERIMENTAL | (age 65 or above) |
| BMS-708163 - Panel 4 | EXPERIMENTAL | (age 65 or above) |
| A | OTHER | - |
| B | EXPERIMENTAL | - |
| C | EXPERIMENTAL | \+ Other |
| 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 |
| 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 |
| Interacting drugs - Cooperstown Cocktail (midazolam, warfarin, (+ vitamin K), caffeine, omeprazole and dextromethorphan) | DRUG | Capsules + Tablets + Oral solution, Oral, Midazolam: 5 mg, Warfarin: 10 mg (vitamin K 10 mg), caffeine: 200 mg, omeprazole: 40 mg, dextromethorphan: 30 mg once daily, Day 1, 1 Day |
| BMS-708163 + Cooperstown Cocktail | DRUG | Capsules + tablets + Oral solution, Oral, BMS-708163: 150 mg + Midazolam: 5 mg, Warfarin: 10 mg (vitamin K 10 mg), caffeine: 200 mg, omeprazole: 40 mg, dextromethorphan: 30 mg, BMS-708163, once daily, days 16-20 midazolam,warfarin, (+ vitamin K), caffeine, omeprazole and dextromethorphan once daily on Day 16, 5 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 being developed by Bristol-Myers Squibb for Alzheimer's disease. It has been studied in healthy volunteers and in patients with Alzheimer's disease, primarily in Phase 1 clinical trials. The drug is not approved and remains in clinical development.
BMS-708163 is developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company has conducted multiple Phase 1 trials of the drug, all of which have been completed.
BMS-708163 is in Phase 1 clinical development. All five trials of the drug have been completed, and there are no active trials currently ongoing. The drug remains investigational and has not been approved by regulatory authorities.
BMS-708163 has been studied in five completed Phase 1 trials, including NCT00726726, NCT00860275, NCT01002079, and NCT01057030. These trials assessed drug interactions and bridging studies in healthy volunteers, with a total enrollment of 393 participants across studies in the United States and India.
BMS-708163 is also known as avagacestat, a name that appears in scientific literature. The drug is a small molecule developed by Bristol-Myers Squibb for Alzheimer's disease, and it has been evaluated in Phase 1 clinical trials.