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

February 4, 2011 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Cypress, California, United States, 90630
        • West Coast Clinical Trials, Llc
      • Glendale, California, United States, 91206
        • California Clinical Trials Medical Group
    • New Jersey
      • Eatontown, New Jersey, United States, 07724
        • Iberica Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A1 (BMS-708163)
Drug: BMS-708163
Capsule, Oral, 50 mg, once daily, 1 Day
Drug: BMS-708163
Capsule, Oral, 125 mg, once daily, 14 Days
Placebo Comparator: A2 (Placebo)
Drug: Placebo
Capsule, Oral, 0 mg, One daily, 1 Day
Drug: Placebo
Capsule, Oral, 0 mg, One daily, 14 Day
Active Comparator: B1 (BMS-708163)
Drug: BMS-708163
Capsule, Oral, 50 mg, once daily, 1 Day
Drug: BMS-708163
Capsule, Oral, 125 mg, once daily, 14 Days
Placebo Comparator: B2 (Placebo)
Drug: Placebo
Capsule, Oral, 0 mg, One daily, 1 Day
Drug: Placebo
Capsule, Oral, 0 mg, One daily, 14 Day

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: Study Day 1 through study completion + 30 days
Study Day 1 through study completion + 30 days

Secondary Outcome Measures

Outcome 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
Time Frame: Study Days 1-8 Period 1 and Days 1, 2, 5, 7, 9, 11, and 13-21 Period 2
Study Days 1-8 Period 1 and Days 1, 2, 5, 7, 9, 11, and 13-21 Period 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

March 2, 2010

First Submitted That Met QC Criteria

March 2, 2010

First Posted (Estimate)

March 3, 2010

Study Record Updates

Last Update Posted (Estimate)

February 7, 2011

Last Update Submitted That Met QC Criteria

February 4, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN156-029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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