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

Randomized, Placebo-controlled, Double-blind, Single- and Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-708163 in Healthy Young Male and Elderly Male and Female Chinese Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01079819

Enrollment

Registered

2010-03-03

Start date

2010-04-30

Completion date

2010-12-31

Last updated

2011-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

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

Interventions

DRUGBMS-708163

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026