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

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 1

Conditions

Alzheimer's Disease

Treatments

Drug: Placebo matching BMS-708163

Drug: BMS-708163 (Gamma-Secretase Inhibitor)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01454115

CN156-001

Details and patient eligibility

About

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.

Enrollment

116 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

116 participants in 14 patient groups

Panel 1: BMS-708163 or Placebo

Experimental group

Description:

Healthy male subjects (age: 18 to 45 years)

Treatment:

Drug: Placebo matching BMS-708163

Drug: BMS-708163 (Gamma-Secretase Inhibitor)

Drug: Placebo matching BMS-708163

Drug: BMS-708163 (Gamma-Secretase Inhibitor)

Panel 2: BMS-708163 or Placebo

Experimental group

Description:

Healthy male subjects (age: 18 to 45 years)

Treatment:

Drug: Placebo matching BMS-708163

Drug: BMS-708163 (Gamma-Secretase Inhibitor)

Drug: Placebo matching BMS-708163

Drug: BMS-708163 (Gamma-Secretase Inhibitor)

Panel 3: BMS-708163 or Placebo

Experimental group

Description:

Healthy male subjects (age: 18 to 45 years)

Treatment:

Drug: Placebo matching BMS-708163

Drug: BMS-708163 (Gamma-Secretase Inhibitor)

Drug: Placebo matching BMS-708163

Drug: BMS-708163 (Gamma-Secretase Inhibitor)

Panel 4: BMS-708163 or Placebo

Experimental group

Description:

Healthy male subjects (age: 18 to 45 years)

Treatment:

Drug: Placebo matching BMS-708163

Drug: BMS-708163 (Gamma-Secretase Inhibitor)

Drug: Placebo matching BMS-708163

Drug: BMS-708163 (Gamma-Secretase Inhibitor)

Panel 5: BMS-708163 or Placebo

Experimental group

Description:

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

Treatment:

Drug: Placebo matching BMS-708163

Drug: BMS-708163 (Gamma-Secretase Inhibitor)

Drug: Placebo matching BMS-708163

Drug: BMS-708163 (Gamma-Secretase Inhibitor)

Panel 6: BMS-708163 or Placebo

Experimental group

Description:

Healthy male subjects (age: 18 to 45 years)

Treatment:

Drug: Placebo matching BMS-708163

Drug: BMS-708163 (Gamma-Secretase Inhibitor)

Drug: Placebo matching BMS-708163

Drug: BMS-708163 (Gamma-Secretase Inhibitor)

Panel 7: BMS-708163 or Placebo

Experimental group

Description:

Healthy male subjects (age: 18 to 45 years)

Treatment:

Drug: Placebo matching BMS-708163

Drug: BMS-708163 (Gamma-Secretase Inhibitor)

Drug: Placebo matching BMS-708163

Drug: BMS-708163 (Gamma-Secretase Inhibitor)

Panel 8: BMS-708163 or Placebo

Experimental group

Description:

Healthy male subjects (age: 18 to 45 years)

Treatment:

Drug: Placebo matching BMS-708163

Drug: BMS-708163 (Gamma-Secretase Inhibitor)

Drug: Placebo matching BMS-708163

Drug: BMS-708163 (Gamma-Secretase Inhibitor)

Panel 9: BMS-708163 or Placebo

Experimental group

Description:

Healthy, elderly male subjects (age: 60 years and greater)

Treatment:

Drug: Placebo matching BMS-708163

Drug: BMS-708163 (Gamma-Secretase Inhibitor)

Drug: Placebo matching BMS-708163

Drug: BMS-708163 (Gamma-Secretase Inhibitor)

Panel 10: BMS-708163 or Placebo

Experimental group

Description:

Healthy, elderly female subjects (age: 60 years and greater)

Treatment:

Drug: Placebo matching BMS-708163

Drug: BMS-708163 (Gamma-Secretase Inhibitor)

Drug: Placebo matching BMS-708163

Drug: BMS-708163 (Gamma-Secretase Inhibitor)

Panel 11: BMS-708163 or Placebo

Experimental group

Description:

Healthy male subjects (age: between 46 to 59 years)

Treatment:

Drug: Placebo matching BMS-708163

Drug: BMS-708163 (Gamma-Secretase Inhibitor)

Drug: Placebo matching BMS-708163

Drug: BMS-708163 (Gamma-Secretase Inhibitor)

Panel 12: BMS-708163 or Placebo

Experimental group

Description:

Healthy male and/or female subjects or subjects with MCI (age: between 60-74 years)

Treatment:

Drug: Placebo matching BMS-708163

Drug: BMS-708163 (Gamma-Secretase Inhibitor)

Drug: Placebo matching BMS-708163

Drug: BMS-708163 (Gamma-Secretase Inhibitor)

Panel 13: BMS-708163 or Placebo

Experimental group

Description:

Healthy male and/or female subjects or with AD or MCI (age: 75 years or greater)

Treatment:

Drug: Placebo matching BMS-708163

Drug: BMS-708163 (Gamma-Secretase Inhibitor)

Drug: Placebo matching BMS-708163

Drug: BMS-708163 (Gamma-Secretase Inhibitor)

Panel 15: BMS-708163 or Placebo

Experimental group

Description:

Healthy young male subjects

Treatment:

Drug: Placebo matching BMS-708163

Drug: BMS-708163 (Gamma-Secretase Inhibitor)

Drug: Placebo matching BMS-708163

Drug: BMS-708163 (Gamma-Secretase Inhibitor)

Trial contacts and locations

Data sourced from clinicaltrials.gov

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