Single Ascending Dose (BMS-813160) Study
Primary Purpose
Accelerated Intimal Hyperplasia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-813160
BMS-813160
BMS-813160
BMS-813160
BMS-813160
BMS-813160
[14C] BMS-813160
Placebo
BMS-813160
BMS-813160
Sponsored by
About this trial
This is an interventional basic science trial for Accelerated Intimal Hyperplasia
Eligibility 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
Sites / Locations
- Covance Clinical Research Unit, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
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 7 [14C] BMS-813160
Arm 8 (BMS-813160 or placebo)
Arm 9 (BMS-813160 or placebo)
Arm Description
Outcomes
Primary Outcome Measures
Safety will be assessed by clinical laboratory results, ECGs, vital signs, and reported adverse events
Secondary Outcome Measures
Pharmacokinetics of BMS-813160
Pharmacodynamics (Plasma MCP-1)
Pharmacodynamics (Circulating monocytes)
Pharmacodynamics (CCR5 phosphorylation and internalization in whole blood)
Full Information
NCT ID
NCT01049165
First Posted
January 12, 2010
Last Updated
February 10, 2011
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT01049165
Brief Title
Single Ascending Dose (BMS-813160) Study
Official Title
Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-813160 in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Accelerated Intimal Hyperplasia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1 (BMS-813160 or placebo)
Arm Type
Active Comparator
Arm Title
Arm 2 (BMS-813160 or placebo)
Arm Type
Active Comparator
Arm Title
Arm 3 (BMS-813160 or placebo)
Arm Type
Active Comparator
Arm Title
Arm 4 (BMS-813160 or placebo)
Arm Type
Active Comparator
Arm Title
Arm 5 (BMS-813160 or placebo)
Arm Type
Active Comparator
Arm Title
Arm 6 (BMS-813160 or placebo)
Arm Type
Active Comparator
Arm Title
Arm 7 [14C] BMS-813160
Arm Type
Active Comparator
Arm Title
Arm 8 (BMS-813160 or placebo)
Arm Type
Active Comparator
Arm Title
Arm 9 (BMS-813160 or placebo)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
BMS-813160
Intervention Description
Oral Solution, Oral, 5 mg, Single dose, 1 day
Intervention Type
Drug
Intervention Name(s)
BMS-813160
Intervention Description
Oral Solution, Oral, 20 mg, Single dose, 1 day
Intervention Type
Drug
Intervention Name(s)
BMS-813160
Intervention Description
Oral Solution, Oral, 60 mg, Single dose, 1 day
Intervention Type
Drug
Intervention Name(s)
BMS-813160
Intervention Description
Oral Solution, Oral, 150 mg, Single dose, 1 day
Intervention Type
Drug
Intervention Name(s)
BMS-813160
Intervention Description
Oral Solution, Oral, 300 mg, Single dose, 1 day
Intervention Type
Drug
Intervention Name(s)
BMS-813160
Intervention Description
Oral Solution, Oral, 600 mg, Single Dose, 1 day
Intervention Type
Drug
Intervention Name(s)
[14C] BMS-813160
Intervention Description
Oral Solution, Oral, 150 mg, Single Dose, 1 day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral Solution, Oral, 0 mg, Single Dose, 1 day
Intervention Type
Drug
Intervention Name(s)
BMS-813160
Intervention Description
Oral Solution, Oral, 1200 mg, Single dose, 1 day
Intervention Type
Drug
Intervention Name(s)
BMS-813160
Intervention Description
Oral Solution, Oral, 2000 mg, Single Dose, 1 day
Primary Outcome Measure Information:
Title
Safety will be assessed by clinical laboratory results, ECGs, vital signs, and reported adverse events
Time Frame
Dosing through Day 5
Secondary Outcome Measure Information:
Title
Pharmacokinetics of BMS-813160
Time Frame
9 times after dosing
Title
Pharmacodynamics (Plasma MCP-1)
Time Frame
9 times post dose
Title
Pharmacodynamics (Circulating monocytes)
Time Frame
5 times post dose
Title
Pharmacodynamics (CCR5 phosphorylation and internalization in whole blood)
Time Frame
5 times post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Covance Clinical Research Unit, Inc.
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53704
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Single Ascending Dose (BMS-813160) Study
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