Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-708163 in Healthy Male Japanese Subjects and a Comparison to Healthy Elderly Japanese Subjects

Bristol-Myers Squibb1 site in 1 country32 target enrollmentOctober 2008

ConditionsHealthy

InterventionsBMS-708163 Placebo

DrugsBMS-708163 Placebo

Overview

Phase: Phase 1
Intervention: BMS-708163
Conditions: Healthy
Sponsor: Bristol-Myers Squibb
Enrollment: 32
Locations: 1
Primary Endpoint: Adverse Events
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics, and pharmacodynamics following 14-day multiple oral doses BMS-708163 in healthy young male Japanese and healthy elderly male and female Japanese subjects

Registry

clinicaltrials.gov

Start Date

October 2008

End Date

July 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Eligibility Criteria

Inclusion Criteria

•Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
•Body Mass Index (BMI) of 19 to 25 kg/m2, inclusive. BMI = weight (kg)/ \[height (m)\]2
•Men, ages 20 to 45, and men and women \[not of childbearing potential (i.e., who are postmenopausal or surgically sterile)\], ages 65 or older. Women are considered surgically sterile only if they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy. Women are considered postmenopausal only if they have had amenorrhea for ≥12 consecutive months, or for women on hormone replacement therapy (HRT), if they have a documented serum follicle stimulating hormone (FSH) level \> 35 mIU/mL

Exclusion Criteria

•Women who are pregnant or breastfeeding
•Women with a positive pregnancy test on enrollment or prior to administration of investigational product
•Sexually active fertile men not using effective birth control if their partners are WOCBP
•Any significant acute or chronic medical illness
•Any current or recent? medical history of gastrointestinal disease that may affect evaluation of study treatment
•History of recent major surgery or gastrointestinal surgery that may impact on evaluation or absorption of study drug
•History of blood donation or blood transfusion within 4 weeks prior to the study treatment
•Intolerance to oral medication or venous access
•QTc interval (Bazett's correction) \>500 ms at screening
•Smoking more than 10 cigarettes per day