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

Bristol-Myers Squibb116 enrolled

Overview

The primary objective is to assess the safety and tolerability of a single oral dose of BMS-708163 in healthy young male subjects and in elderly male and female subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

116

Conditions

Alzheimer's Disease

Interventions

BMS-708163 (Gamma-Secretase Inhibitor)DRUG

Oral Solution, Oral, 0.3 mg, Once daily, once

BMS-708163 (Gamma-Secretase Inhibitor)DRUG

Oral Solution, Oral, 1.5 mg, Once daily, once

BMS-708163 (Gamma-Secretase Inhibitor)DRUG

Oral Solution, Oral, 5.0 mg, Once daily, once

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Panels 1- 8 and Panels 14-15: healthy male subjects between the ages of 18 to 45 * Panels 9 and 10: healthy elderly males and females ages 60 and greater * Panel 11: healthy males between the ages of 46-59 * Panel 12: males and/or females either healthy or with mild cognitive impairment (MCI) between the ages of 60 and 74 * Panel 13: males and/or females, healthy or with Alzheimer's disease (AD) or MCI that were 75 years of age or greater * Acceptable medical history, physical examinations, vital signs, electrocardiograms, hemoccult stool tests, and clinical laboratory evaluations

Outcomes

Primary Outcomes

Safety and tolerability of Single doses of BMS-708163 in the range of 0.3 to 800 mg in the healthy subjects

Based on adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests