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Completed

NCT Number: NCT01079819

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

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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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

West Coast Clinical Trials, Llc, Cypress, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-708163

Drug

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

Placebo

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 3, 2010
Registry last updated
Feb 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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