ClinicalTrials.gov
ClinicalTrials.gov Menu

Single Ascending Dose (BMS-813160) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01049165
Recruitment Status : Completed
First Posted : January 14, 2010
Last Update Posted : February 11, 2011
Sponsor:
Information provided by:
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Accelerated Intimal Hyperplasia Drug: BMS-813160 Drug: [14C] BMS-813160 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-813160 in Healthy Subjects
Study Start Date : February 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Arm Intervention/treatment
Active Comparator: Arm 1 (BMS-813160 or placebo) Drug: BMS-813160
Oral Solution, Oral, 5 mg, Single dose, 1 day

Drug: Placebo
Oral Solution, Oral, 0 mg, Single Dose, 1 day

Active Comparator: Arm 2 (BMS-813160 or placebo) Drug: BMS-813160
Oral Solution, Oral, 20 mg, Single dose, 1 day

Drug: Placebo
Oral Solution, Oral, 0 mg, Single Dose, 1 day

Active Comparator: Arm 3 (BMS-813160 or placebo) Drug: BMS-813160
Oral Solution, Oral, 60 mg, Single dose, 1 day

Drug: Placebo
Oral Solution, Oral, 0 mg, Single Dose, 1 day

Active Comparator: Arm 4 (BMS-813160 or placebo) Drug: BMS-813160
Oral Solution, Oral, 150 mg, Single dose, 1 day

Drug: Placebo
Oral Solution, Oral, 0 mg, Single Dose, 1 day

Active Comparator: Arm 5 (BMS-813160 or placebo) Drug: BMS-813160
Oral Solution, Oral, 300 mg, Single dose, 1 day

Drug: Placebo
Oral Solution, Oral, 0 mg, Single Dose, 1 day

Active Comparator: Arm 6 (BMS-813160 or placebo) Drug: BMS-813160
Oral Solution, Oral, 600 mg, Single Dose, 1 day

Drug: Placebo
Oral Solution, Oral, 0 mg, Single Dose, 1 day

Active Comparator: Arm 7 [14C] BMS-813160 Drug: [14C] BMS-813160
Oral Solution, Oral, 150 mg, Single Dose, 1 day

Active Comparator: Arm 8 (BMS-813160 or placebo) Drug: Placebo
Oral Solution, Oral, 0 mg, Single Dose, 1 day

Drug: BMS-813160
Oral Solution, Oral, 1200 mg, Single dose, 1 day

Active Comparator: Arm 9 (BMS-813160 or placebo) Drug: BMS-813160
Oral Solution, Oral, 2000 mg, Single Dose, 1 day




Primary Outcome Measures :
  1. Safety will be assessed by clinical laboratory results, ECGs, vital signs, and reported adverse events [ Time Frame: Dosing through Day 5 ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01049165


Locations
United States, Wisconsin
Covance Clinical Research Unit, Inc.
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01049165     History of Changes
Other Study ID Numbers: CV202-001
First Posted: January 14, 2010    Key Record Dates
Last Update Posted: February 11, 2011
Last Verified: February 2011

Additional relevant MeSH terms:
Hyperplasia
Pathologic Processes