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

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: Placebo; Drug: BMS-708163

• Registration Number: NCT01079819
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-03-02
• Study First Submitted QC: 2010-03-02
• Study First Posted: 2010-03-03
• Study Start: 2010-04
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-04
• Last Update Posted: 2011-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B2 (Placebo)	Placebo	-
A1 (BMS-708163)	BMS-708163	-
A2 (Placebo)	Placebo	-
B1 (BMS-708163)	BMS-708163	-

Primary Outcome Measures

Name	Time	Method
Safety assessments will be based on adverse event reports and the results of vital sign measurements, ECGs, physical exams and clinical laboratory tests. Adverse events will be tabulated and reviewed for potential significance and clinical importance	Study Day 1 through study completion + 30 days

Secondary Outcome Measures

Name	Time	Method
Single-dose pharmacokinetic parameters (Cmax, Tmax, AUC(0-T), AUC(INF), T-HALF and multiple-dose pk parameters (Cmax, Tmax, Cmin, AUC(TAU), T-HALF, and accumulation index will be derived from plasma concentration versus time data	Study Days 1-8 Period 1 and Days 1, 2, 5, 7, 9, 11, and 13-21 Period 2

Trial Locations

Locations (3)

West Coast Clinical Trials, Llc; 🇺🇸 Cypress, California, United States

California Clinical Trials Medical Group; 🇺🇸 Glendale, California, United States

Iberica Clinical Research Center; 🇺🇸 Eatontown, New Jersey, United States