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Completed

NCT Number: NCT01049165

Single Ascending Dose (BMS-813160) Study

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

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Key information

Conditions

Accelerated Intimal Hyperplasia

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit, Inc.

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-813160

Drug

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

[14C] BMS-813160

Drug

Oral Solution, Oral, 150 mg, Single Dose, 1 day

Placebo

Drug

Oral Solution, Oral, 0 mg, Single Dose, 1 day

Primary outcomes

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

    Time frame: Dosing through Day 5

Secondary outcomes

  1. Pharmacokinetics of BMS-813160

    Time frame: 9 times after dosing

  2. Pharmacodynamics (Plasma MCP-1)

    Time frame: 9 times post dose

  3. Pharmacodynamics (Circulating monocytes)

    Time frame: 5 times post dose

  4. Pharmacodynamics (CCR5 phosphorylation and internalization in whole blood)

    Time frame: 5 times post-dose

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-813160 in Healthy Subjects

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 14, 2010
Registry last updated
Feb 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.