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Safety Study of Multiple-dose of Gamma-secretase Inhibitor in Healthy Male Japanese and Healthy Elderly Japanese

NCT00828646 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2011-01-07

No results posted yet for this study

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

Conditions

  • Healthy

Interventions

DRUG

BMS-708163

Capsules, Oral, 50 mg, once daily, 14 days

DRUG

BMS-708163

Capsules, Oral, 100 mg/day, once daily, 14 days

DRUG

BMS-708163

Capsules, Oral, 75 or 100 mg/day, once daily, 14 days

DRUG

Placebo

Capsules, Oral, once daily, 14 days

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00828646 on ClinicalTrials.gov