Single Ascending Dose (BMS-813160) Study

Bristol-Myers Squibb70 enrolled

Overview

The primary purpose of this study is to evaluate the safety and tolerability of single oral doses of BMS-813160 in healthy subjects

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Accelerated Intimal Hyperplasia

Interventions

BMS-813160DRUG

Oral Solution, Oral, 5 mg, Single dose, 1 day

BMS-813160DRUG

Oral Solution, Oral, 20 mg, Single dose, 1 day

BMS-813160DRUG

Oral Solution, Oral, 60 mg, Single dose, 1 day

BMS-813160

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Men and women (not of child bearing potential) ages 18 to 45 * Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations Exclusion Criteria: * Women of Child Bearing Potential * Organ dysfunction or any clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

Locations (1)

Covance Clinical Research Unit, Inc.

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Safety will be assessed by clinical laboratory results, ECGs, vital signs, and reported adverse events

Time frame: Dosing through Day 5

Secondary Outcomes

Pharmacokinetics of BMS-813160

Time frame: 9 times after dosing

Pharmacodynamics (Plasma MCP-1)

Time frame: 9 times post dose

Pharmacodynamics (Circulating monocytes)

Time frame: 5 times post dose

Pharmacodynamics (CCR5 phosphorylation and internalization in whole blood)

Time frame: 5 times post-dose

Data from ClinicalTrials.gov

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