Single Ascending Dose (BMS-813160) Study

NCT01049165 | Completed Phase 1

• 1 other identifier: CV202-001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Accelerated Intimal Hyperplasia

Outcome Measures

Primary Outcomes (1)

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

  Dosing through Day 5

Secondary Outcomes (4)

• Pharmacokinetics of BMS-813160

  9 times after dosing

• Pharmacodynamics (Plasma MCP-1)

  9 times post dose

• Pharmacodynamics (Circulating monocytes)

  5 times post dose

• Pharmacodynamics (CCR5 phosphorylation and internalization in whole blood)

  5 times post-dose

Study Arms (9)

Arm 1 (BMS-813160 or placebo)

ACTIVE COMPARATOR

Drug: BMS-813160; Drug: Placebo

Arm 2 (BMS-813160 or placebo)

ACTIVE COMPARATOR

Drug: BMS-813160; Drug: Placebo

Arm 3 (BMS-813160 or placebo)

ACTIVE COMPARATOR

Drug: BMS-813160; Drug: Placebo

Arm 4 (BMS-813160 or placebo)

ACTIVE COMPARATOR

Drug: BMS-813160; Drug: Placebo

Arm 5 (BMS-813160 or placebo)

ACTIVE COMPARATOR

Drug: BMS-813160; Drug: Placebo

Arm 6 (BMS-813160 or placebo)

ACTIVE COMPARATOR

Drug: BMS-813160; Drug: Placebo

Arm 7 [14C] BMS-813160

ACTIVE COMPARATOR

Drug: [14C] BMS-813160

Arm 8 (BMS-813160 or placebo)

ACTIVE COMPARATOR

Drug: Placebo; Drug: BMS-813160

Arm 9 (BMS-813160 or placebo)

ACTIVE COMPARATOR

Drug: BMS-813160

Interventions

BMS-813160 DRUG

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

Arm 1 (BMS-813160 or placebo)

[14C] BMS-813160 DRUG

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

Arm 7 [14C] BMS-813160

Placebo DRUG

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

Arm 1 (BMS-813160 or placebo); Arm 2 (BMS-813160 or placebo); Arm 3 (BMS-813160 or placebo); Arm 4 (BMS-813160 or placebo); Arm 5 (BMS-813160 or placebo); Arm 6 (BMS-813160 or placebo); Arm 8 (BMS-813160 or placebo)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Women of Child Bearing Potential
• Organ dysfunction or any clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Covance Clinical Research Unit, Inc.

Madison, Wisconsin, 53704, United States

Location

Related Links

• Investigator Inquiry form

MeSH Terms

Interventions

BMS-813160

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 14, 2010
• Study Start: February 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 11, 2011

Record last verified: 2011-02

Locations

US (1)