search
Back to results

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
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Accelerated Intimal Hyperplasia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

First Posted
January 12, 2010
Last Updated
February 10, 2011
Sponsor
Bristol-Myers Squibb
search

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

We'll reach out to this number within 24 hrs