Study to Evaluate the Safety, Pharmacokinetics and Tolerability of BMS-708163

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: BMS-708163 (Gamma-Secretase Inhibitor); Drug: Placebo matching BMS-708163

• Registration Number: NCT01454115
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Study First Submitted: 2011-10-07
• Study First Submitted QC: 2011-10-17
• Study First Posted: 2011-10-18
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-18
• Last Update Posted: 2011-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• Panels 1- 8 and Panels 14-15: healthy male subjects between the ages of 18 to 45
• Panels 9 and 10: healthy elderly males and females ages 60 and greater
• Panel 11: healthy males between the ages of 46-59
• Panel 12: males and/or females either healthy or with mild cognitive impairment (MCI) between the ages of 60 and 74
• Panel 13: males and/or females, healthy or with Alzheimer's disease (AD) or MCI that were 75 years of age or greater
• Acceptable medical history, physical examinations, vital signs, electrocardiograms, hemoccult stool tests, and clinical laboratory evaluations

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Panel 1: BMS-708163 or Placebo	BMS-708163 (Gamma-Secretase Inhibitor)	Healthy male subjects (age: 18 to 45 years)
Panel 1: BMS-708163 or Placebo	Placebo matching BMS-708163	Healthy male subjects (age: 18 to 45 years)
Panel 2: BMS-708163 or Placebo	BMS-708163 (Gamma-Secretase Inhibitor)	Healthy male subjects (age: 18 to 45 years)
Panel 2: BMS-708163 or Placebo	Placebo matching BMS-708163	Healthy male subjects (age: 18 to 45 years)
Panel 3: BMS-708163 or Placebo	BMS-708163 (Gamma-Secretase Inhibitor)	Healthy male subjects (age: 18 to 45 years)
Panel 3: BMS-708163 or Placebo	Placebo matching BMS-708163	Healthy male subjects (age: 18 to 45 years)
Panel 4: BMS-708163 or Placebo	BMS-708163 (Gamma-Secretase Inhibitor)	Healthy male subjects (age: 18 to 45 years)
Panel 4: BMS-708163 or Placebo	Placebo matching BMS-708163	Healthy male subjects (age: 18 to 45 years)
Panel 5: BMS-708163 or Placebo	BMS-708163 (Gamma-Secretase Inhibitor)	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 5: BMS-708163 or Placebo	Placebo matching BMS-708163	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	BMS-708163 (Gamma-Secretase Inhibitor)	Healthy male subjects (age: 18 to 45 years)
Panel 6: BMS-708163 or Placebo	Placebo matching BMS-708163	Healthy male subjects (age: 18 to 45 years)
Panel 7: BMS-708163 or Placebo	BMS-708163 (Gamma-Secretase Inhibitor)	Healthy male subjects (age: 18 to 45 years)
Panel 7: BMS-708163 or Placebo	Placebo matching BMS-708163	Healthy male subjects (age: 18 to 45 years)
Panel 8: BMS-708163 or Placebo	BMS-708163 (Gamma-Secretase Inhibitor)	Healthy male subjects (age: 18 to 45 years)
Panel 8: BMS-708163 or Placebo	Placebo matching BMS-708163	Healthy male subjects (age: 18 to 45 years)
Panel 9: BMS-708163 or Placebo	BMS-708163 (Gamma-Secretase Inhibitor)	Healthy, elderly male subjects (age: 60 years and greater)
Panel 9: BMS-708163 or Placebo	Placebo matching BMS-708163	Healthy, elderly male subjects (age: 60 years and greater)
Panel 10: BMS-708163 or Placebo	BMS-708163 (Gamma-Secretase Inhibitor)	Healthy, elderly female subjects (age: 60 years and greater)
Panel 10: BMS-708163 or Placebo	Placebo matching BMS-708163	Healthy, elderly female subjects (age: 60 years and greater)
Panel 11: BMS-708163 or Placebo	BMS-708163 (Gamma-Secretase Inhibitor)	Healthy male subjects (age: between 46 to 59 years)
Panel 11: BMS-708163 or Placebo	Placebo matching BMS-708163	Healthy male subjects (age: between 46 to 59 years)
Panel 12: BMS-708163 or Placebo	BMS-708163 (Gamma-Secretase Inhibitor)	Healthy male and/or female subjects or subjects with MCI (age: between 60-74 years)
Panel 12: BMS-708163 or Placebo	Placebo matching BMS-708163	Healthy male and/or female subjects or subjects with MCI (age: between 60-74 years)
Panel 13: BMS-708163 or Placebo	BMS-708163 (Gamma-Secretase Inhibitor)	Healthy male and/or female subjects or with AD or MCI (age: 75 years or greater)
Panel 13: BMS-708163 or Placebo	Placebo matching BMS-708163	Healthy male and/or female subjects or with AD or MCI (age: 75 years or greater)
Panel 15: BMS-708163 or Placebo	BMS-708163 (Gamma-Secretase Inhibitor)	Healthy young male subjects
Panel 15: BMS-708163 or Placebo	Placebo matching BMS-708163	Healthy young male subjects

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of Single doses of BMS-708163 in the range of 0.3 to 800 mg in the healthy subjects	Within 28 days of dosing	Based on adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests

Secondary Outcome Measures

Name	Time	Method
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
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