Multiple Dose Japanese Bridging Study

NCT ID: NCT01057030

Last Updated: 2011-01-25

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

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-06-30

Brief Summary

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The purpose of this study is to assess the safety and tolerability of multiple oral daily doses of BMS-708163 in healthy young male subjects

Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A1 (BMS-708163)

Healthy Japanese Subjects

Group Type ACTIVE_COMPARATOR

BMS-708163

Intervention Type DRUG

Capsules, Oral, 125 mg, once daily, 14 days

A2 (Placebo)

Healthy Japanese Subjects

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Capsules, Oral, 0 mg, once daily, 14 days

B1 (BMS-708163)

Healthy Non-Japanese Subjects

Group Type ACTIVE_COMPARATOR

BMS-708163

Intervention Type DRUG

Capsules, Oral, 125 mg, once daily, 14 days

B2 (Placebo)

Healthy Non-Japanese Subjects

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Capsules, Oral, 0 mg, once daily, 14 days

Interventions

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BMS-708163

Capsules, Oral, 125 mg, once daily, 14 days

Intervention Type DRUG

Placebo

Capsules, Oral, 0 mg, once daily, 14 days

Intervention Type DRUG

Other Intervention Names

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(GAMMA SECRETASE inhibitor)

Eligibility Criteria

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Inclusion Criteria

* Healthy Japanese and non-Japanese subjects
* Japanese subjects must be first generation Japanese and must demonstrate both maternal and paternal Japanese ancestry
* Non-Japanese subjects must not be of Japanese or Asian descent, ie, neither parent nor grandparent was born in Japan or in any Asian country
* BMI of 19 to 25 kg/m², for Japanese and non-Japanese subjects
* Men ages 20 to 45 years

Exclusion Criteria

* Serum creatinine values above the normal range
* Urine protein or blood levels above the normal range
* Liver function tests above the normal range
* TSH, free T3, or free T4 outside the normal range
* Amylase or lipase levels above the normal range
* Positive Fecal Immunochemical Test (FIT™)
Minimum Eligible Age

20 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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California Clinical Trials Medical Group

Glendale, California, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CN156-038

Identifier Type: -

Identifier Source: org_study_id

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