Multiple Dose Japanese Bridging Study

Bristol-Myers Squibb22 enrolled

Overview

The purpose of this study is to assess the safety and tolerability of multiple oral daily doses of BMS-708163 in healthy young male subjects

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

Conditions

Alzheimer Disease

Interventions

BMS-708163DRUG

Capsules, Oral, 125 mg, once daily, 14 days

PlaceboDRUG

Capsules, Oral, 0 mg, once daily, 14 days

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy Japanese and non-Japanese subjects * Japanese subjects must be first generation Japanese and must demonstrate both maternal and paternal Japanese ancestry * Non-Japanese subjects must not be of Japanese or Asian descent, ie, neither parent nor grandparent was born in Japan or in any Asian country * BMI of 19 to 25 kg/m², for Japanese and non-Japanese subjects * Men ages 20 to 45 years Exclusion Criteria: * Serum creatinine values above the normal range * Urine protein or blood levels above the normal range * Liver function tests above the normal range * TSH, free T3, or free T4 outside the normal range * Amylase or lipase levels above the normal range * Positive Fecal Immunochemical Test (FIT™)

Locations (1)

California Clinical Trials Medical Group

Glendale, California, United States

Outcomes

Primary Outcomes

BMS-708163 or placebo in Japanese and non-Japanese: Safety and tolerability (AE's, ECG, vital signs, safety labs)

Time frame: Every day for 28 days

Secondary Outcomes

BMS-708163 pharmacokinetic parameters (Cmax, Cmin, Ctrough, Tmax, AUC(TAU), AI, and CLT/F and T-HALF (only following Day 14 dose))

Time frame: Days 1, 7, and 14

Data from ClinicalTrials.gov

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