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

NCT ID: NCT01454115

Last Updated: 2011-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Panel 1: BMS-708163 or Placebo

Healthy male subjects (age: 18 to 45 years)

Group Type EXPERIMENTAL

BMS-708163 (Gamma-Secretase Inhibitor)

Intervention Type DRUG

Oral Solution, Oral, 0.3 mg, Once daily, once

Placebo matching BMS-708163

Intervention Type DRUG

Oral Solution, Oral, 0 mg, Once daily, once

Panel 2: BMS-708163 or Placebo

Healthy male subjects (age: 18 to 45 years)

Group Type EXPERIMENTAL

BMS-708163 (Gamma-Secretase Inhibitor)

Intervention Type DRUG

Oral Solution, Oral, 1.5 mg, Once daily, once

Placebo matching BMS-708163

Intervention Type DRUG

Oral Solution, Oral, 0 mg, Once daily, once

Panel 3: BMS-708163 or Placebo

Healthy male subjects (age: 18 to 45 years)

Group Type EXPERIMENTAL

BMS-708163 (Gamma-Secretase Inhibitor)

Intervention Type DRUG

Oral Solution, Oral, 5.0 mg, Once daily, once

Placebo matching BMS-708163

Intervention Type DRUG

Oral Solution, Oral, 0 mg, Once daily, once

Panel 4: BMS-708163 or Placebo

Healthy male subjects (age: 18 to 45 years)

Group Type EXPERIMENTAL

BMS-708163 (Gamma-Secretase Inhibitor)

Intervention Type DRUG

Oral Solution, Oral, 15.0 mg, Once daily, once

Placebo matching BMS-708163

Intervention Type DRUG

Oral Solution, Oral, 0 mg, Once daily, once

Panel 5: BMS-708163 or Placebo

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

Group Type EXPERIMENTAL

BMS-708163 (Gamma-Secretase Inhibitor)

Intervention Type DRUG

Oral Solution, Oral, 50 mg, Once daily, once

BMS-708163 (Gamma-Secretase Inhibitor)

Intervention Type DRUG

Capsule, Oral, 50 mg, Once daily, once

Placebo matching BMS-708163

Intervention Type DRUG

Oral Solution, Oral, 0 mg, Once daily, once

Placebo matching BMS-708163

Intervention Type DRUG

Capsule, Oral, 0 mg, Once daily, once

Panel 6: BMS-708163 or Placebo

Healthy male subjects (age: 18 to 45 years)

Group Type EXPERIMENTAL

BMS-708163 (Gamma-Secretase Inhibitor)

Intervention Type DRUG

Oral Solution, Oral, 100 mg, Once daily, once

Placebo matching BMS-708163

Intervention Type DRUG

Oral Solution, Oral, 0 mg, Once daily, once

Panel 7: BMS-708163 or Placebo

Healthy male subjects (age: 18 to 45 years)

Group Type EXPERIMENTAL

BMS-708163 (Gamma-Secretase Inhibitor)

Intervention Type DRUG

Oral Solution, Oral, 200 mg, Once daily, once

Placebo matching BMS-708163

Intervention Type DRUG

Oral Solution, Oral, 0 mg, Once daily, once

Panel 8: BMS-708163 or Placebo

Healthy male subjects (age: 18 to 45 years)

Group Type EXPERIMENTAL

BMS-708163 (Gamma-Secretase Inhibitor)

Intervention Type DRUG

Oral Solution, Oral, 400 mg, Once daily, once

Placebo matching BMS-708163

Intervention Type DRUG

Oral Solution, Oral, 0 mg, Once daily, once

Panel 9: BMS-708163 or Placebo

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

Group Type EXPERIMENTAL

BMS-708163 (Gamma-Secretase Inhibitor)

Intervention Type DRUG

Oral Solution, Oral, 50 mg, Once daily, once

Placebo matching BMS-708163

Intervention Type DRUG

Oral Solution, Oral, 0 mg, Once daily, once

Panel 10: BMS-708163 or Placebo

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

Group Type EXPERIMENTAL

BMS-708163 (Gamma-Secretase Inhibitor)

Intervention Type DRUG

Oral Solution, Oral, 50 mg, Once daily, once

Placebo matching BMS-708163

Intervention Type DRUG

Oral Solution, Oral, 0 mg, Once daily, once

Panel 11: BMS-708163 or Placebo

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

Group Type EXPERIMENTAL

BMS-708163 (Gamma-Secretase Inhibitor)

Intervention Type DRUG

Capsule, Oral, 50 mg, Once daily, once

Placebo matching BMS-708163

Intervention Type DRUG

Capsule, Oral, 0 mg, Once daily, once

Panel 12: BMS-708163 or Placebo

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

Group Type EXPERIMENTAL

BMS-708163 (Gamma-Secretase Inhibitor)

Intervention Type DRUG

Capsule, Oral, 50 mg, Once daily, once

Placebo matching BMS-708163

Intervention Type DRUG

Capsule, Oral, 0 mg, Once daily, once

Panel 13: BMS-708163 or Placebo

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

Group Type EXPERIMENTAL

BMS-708163 (Gamma-Secretase Inhibitor)

Intervention Type DRUG

Capsule, Oral, 50 mg, Once daily, once

Placebo matching BMS-708163

Intervention Type DRUG

Capsule, Oral, 0 mg, Once daily, once

Panel 15: BMS-708163 or Placebo

Healthy young male subjects

Group Type EXPERIMENTAL

BMS-708163 (Gamma-Secretase Inhibitor)

Intervention Type DRUG

Oral Solution, Oral, 800 mg, Once daily, once

Placebo matching BMS-708163

Intervention Type DRUG

Oral Solution, Oral, 0 mg, Once daily, once

Interventions

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BMS-708163 (Gamma-Secretase Inhibitor)

Oral Solution, Oral, 0.3 mg, Once daily, once

Intervention Type DRUG

BMS-708163 (Gamma-Secretase Inhibitor)

Oral Solution, Oral, 1.5 mg, Once daily, once

Intervention Type DRUG

BMS-708163 (Gamma-Secretase Inhibitor)

Oral Solution, Oral, 5.0 mg, Once daily, once

Intervention Type DRUG

BMS-708163 (Gamma-Secretase Inhibitor)

Oral Solution, Oral, 15.0 mg, Once daily, once

Intervention Type DRUG

BMS-708163 (Gamma-Secretase Inhibitor)

Oral Solution, Oral, 50 mg, Once daily, once

Intervention Type DRUG

BMS-708163 (Gamma-Secretase Inhibitor)

Oral Solution, Oral, 100 mg, Once daily, once

Intervention Type DRUG

BMS-708163 (Gamma-Secretase Inhibitor)

Oral Solution, Oral, 200 mg, Once daily, once

Intervention Type DRUG

BMS-708163 (Gamma-Secretase Inhibitor)

Oral Solution, Oral, 400 mg, Once daily, once

Intervention Type DRUG

BMS-708163 (Gamma-Secretase Inhibitor)

Capsule, Oral, 50 mg, Once daily, once

Intervention Type DRUG

BMS-708163 (Gamma-Secretase Inhibitor)

Oral Solution, Oral, 800 mg, Once daily, once

Intervention Type DRUG

Placebo matching BMS-708163

Oral Solution, Oral, 0 mg, Once daily, once

Intervention Type DRUG

Placebo matching BMS-708163

Capsule, Oral, 0 mg, Once daily, once

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

References

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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.

Reference Type DERIVED
PMID: 22381714 (View on PubMed)

Other Identifiers

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CN156-001

Identifier Type: -

Identifier Source: org_study_id