Relative Bioavailability Study of Four Experimental Formulations for Alzheimer's Disease

NCT ID: NCT00901498

Last Updated: 2011-01-07

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-07-31

Brief Summary

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The purpose of this study is to assess the bioavailability of four experimental formulations relative to the current reference formulation used in the Phase 2 study.

Detailed Description

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Conditions

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Alzheimer's Disease Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Treatment A (Reference)

Group Type EXPERIMENTAL

BMS-708163

Intervention Type DRUG

Oral, 25 mg Hard Gelatin Capsule, Size #2, 150 mg, Once per period of 3, 7 days between dosings. Will be compared with any 2 comparators.

Treatment B

Group Type ACTIVE_COMPARATOR

BMS-708163

Intervention Type DRUG

Oral, 75 mg Tablet Formulation 1, 150 mg, Once per period of 3, 7 days between dosings

Treatment C

Group Type ACTIVE_COMPARATOR

BMS-708163

Intervention Type DRUG

Oral, 50 mg Hard Gelatin Capsule, Size #0, 150 mg, Once per period of 3, 7 days between dosings

Treatment D

Group Type ACTIVE_COMPARATOR

BMS-708163

Intervention Type DRUG

Oral, 75 mg Soft Gelatin Capsule, 150 mg, Once per period of 3, 7 days between dosings

Treatment E

Group Type ACTIVE_COMPARATOR

BMS-708163

Intervention Type DRUG

Oral, 75 mg Tablet Formulation 2, 150 mg, Once per period of 3, 7 days between dosings

Interventions

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BMS-708163

Oral, 25 mg Hard Gelatin Capsule, Size #2, 150 mg, Once per period of 3, 7 days between dosings. Will be compared with any 2 comparators.

Intervention Type DRUG

BMS-708163

Oral, 75 mg Tablet Formulation 1, 150 mg, Once per period of 3, 7 days between dosings

Intervention Type DRUG

BMS-708163

Oral, 50 mg Hard Gelatin Capsule, Size #0, 150 mg, Once per period of 3, 7 days between dosings

Intervention Type DRUG

BMS-708163

Oral, 75 mg Soft Gelatin Capsule, 150 mg, Once per period of 3, 7 days between dosings

Intervention Type DRUG

BMS-708163

Oral, 75 mg Tablet Formulation 2, 150 mg, Once per period of 3, 7 days between dosings

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Young healthy male subjects

Exclusion Criteria

* Women
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Mds Pharma Services (Us) Inc.

Neptune City, New Jersey, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CN156-004

Identifier Type: -

Identifier Source: org_study_id

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