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The primary objective is to assess the safety and tolerability of a single oral dose of BMS-708163 in healthy young male subjects and in elderly male and female subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-708163 (Gamma-Secretase Inhibitor) | Drug | Oral Solution, Oral, 0.3 mg, Once daily, once |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of Single doses of BMS-708163 in the range of 0.3 to 800 mg in the healthy subjects | Based on adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests | Within 28 days of dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of BMS-708163 on cortisol and QT interval corrected for heart rate | Within 28 days of dosing | |
| Effect of BMS-708163 on thyroid stimulating hormone (TSH), free triiodothyronine (T3), free thyroxine (T4), and lymphocyte subsets | Within 28 days of dosing |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22381714 | Derived | Tong G, Wang JS, Sverdlov O, Huang SP, Slemmon R, Croop R, Castaneda L, Gu H, Wong O, Li H, Berman RM, Smith C, Albright CF, Dockens RC. Multicenter, randomized, double-blind, placebo-controlled, single-ascending dose study of the oral gamma-secretase inhibitor BMS-708163 (Avagacestat): tolerability profile, pharmacokinetic parameters, and pharmacodynamic markers. Clin Ther. 2012 Mar;34(3):654-67. doi: 10.1016/j.clinthera.2012.01.022. Epub 2012 Feb 28. |
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|
| 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 |
|
| BMS-708163 (Gamma-Secretase Inhibitor) | Drug | Oral Solution, Oral, 1.5 mg, Once daily, once |
|
| BMS-708163 (Gamma-Secretase Inhibitor) | Drug | Oral Solution, Oral, 5.0 mg, Once daily, once |
|
| BMS-708163 (Gamma-Secretase Inhibitor) | Drug | Oral Solution, Oral, 15.0 mg, Once daily, once |
|
| BMS-708163 (Gamma-Secretase Inhibitor) | Drug | Oral Solution, Oral, 50 mg, Once daily, once |
|
| BMS-708163 (Gamma-Secretase Inhibitor) | Drug | Oral Solution, Oral, 100 mg, Once daily, once |
|
| BMS-708163 (Gamma-Secretase Inhibitor) | Drug | Oral Solution, Oral, 200 mg, Once daily, once |
|
| BMS-708163 (Gamma-Secretase Inhibitor) | Drug | Oral Solution, Oral, 400 mg, Once daily, once |
|
| BMS-708163 (Gamma-Secretase Inhibitor) | Drug | Capsule, Oral, 50 mg, Once daily, once |
|
| BMS-708163 (Gamma-Secretase Inhibitor) | Drug | Oral Solution, Oral, 800 mg, Once daily, once |
|
| Placebo matching BMS-708163 | Drug | Oral Solution, Oral, 0 mg, Once daily, once |
|
| Placebo matching BMS-708163 | Drug | Capsule, Oral, 0 mg, Once daily, once |
|
| Bioavailability of BMS-708163 from a capsule formulation relative to a solution formulation | Within 28 days of dosing |
| Effect of food on the PK of BMS-708163 administered as a capsule formulation | Within 28 days of dosing |
| Maximum observed plasma concentration (Cmax) of BMS-708163 | Within 28 days of dosing |
| Time of maximum observed plasma concentration (Tmax) of BMS-708163 | Within 28 days of dosing |
| Area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration [AUC(0-T)] of BMS-708163 | Within 28 days of dosing |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-708163 | Within 28 days of dosing |
| Plasma half-life (T-HALF) of BMS-708163 | Within 28 days of dosing |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C554092 | BMS 708163 |
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