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

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-12-31

Brief Summary

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The purpose of the study is to evaluate the pharmacokinetics, safety and tolerability of BMS-708163 administered as single and multiple doses in Chinese subjects

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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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A1 (BMS-708163)

Group Type ACTIVE_COMPARATOR

BMS-708163

Intervention Type DRUG

Capsule, Oral, 50 mg, once daily, 1 Day

A2 (Placebo)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Capsule, Oral, 0 mg, One daily, 1 Day

B1 (BMS-708163)

Group Type ACTIVE_COMPARATOR

BMS-708163

Intervention Type DRUG

Capsule, Oral, 125 mg, once daily, 14 Days

B2 (Placebo)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Capsule, Oral, 0 mg, One daily, 14 Day

Interventions

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BMS-708163

Capsule, Oral, 50 mg, once daily, 1 Day

Intervention Type DRUG

BMS-708163

Capsule, Oral, 125 mg, once daily, 14 Days

Intervention Type DRUG

Placebo

Capsule, Oral, 0 mg, One daily, 1 Day

Intervention Type DRUG

Placebo

Capsule, Oral, 0 mg, One daily, 14 Day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects 18-45 yrs old and 65 yrs or older inclusive and postmenopausal female 65 yrs or older

Exclusion Criteria

* Women of childbearing potential
* Gastrointestinal disorders
* Bleeding disorders
* Peptic ulcer disease
* Abnormal ECG
* Abnormal Clinical laboratory tests
* Abnormal Thyroid
* Congestive heart failure
* Cholecystectomy
* Asthma
* Hypertension
* Inability to tolerate oral medication
* Inability to be venipunctured and/or tolerate venous access

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No