Single Ascending Dose (BMS-813160) Study

February 10, 2011 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Completed

Conditions

Accelerated Intimal Hyperplasia

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Wisconsin
  - Madison, Wisconsin, United States, 53704
    - Covance Clinical Research Unit, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1 (BMS-813160 or placebo)	Drug: BMS-813160 Oral Solution, Oral, 5 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 20 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 60 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 150 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 300 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 600 mg, Single Dose, 1 day Drug: Placebo Oral Solution, Oral, 0 mg, Single Dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 1200 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 2000 mg, Single Dose, 1 day
Active Comparator: Arm 2 (BMS-813160 or placebo)	Drug: BMS-813160 Oral Solution, Oral, 5 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 20 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 60 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 150 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 300 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 600 mg, Single Dose, 1 day Drug: Placebo Oral Solution, Oral, 0 mg, Single Dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 1200 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 2000 mg, Single Dose, 1 day
Active Comparator: Arm 3 (BMS-813160 or placebo)	Drug: BMS-813160 Oral Solution, Oral, 5 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 20 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 60 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 150 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 300 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 600 mg, Single Dose, 1 day Drug: Placebo Oral Solution, Oral, 0 mg, Single Dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 1200 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 2000 mg, Single Dose, 1 day
Active Comparator: Arm 4 (BMS-813160 or placebo)	Drug: BMS-813160 Oral Solution, Oral, 5 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 20 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 60 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 150 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 300 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 600 mg, Single Dose, 1 day Drug: Placebo Oral Solution, Oral, 0 mg, Single Dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 1200 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 2000 mg, Single Dose, 1 day
Active Comparator: Arm 5 (BMS-813160 or placebo)	Drug: BMS-813160 Oral Solution, Oral, 5 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 20 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 60 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 150 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 300 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 600 mg, Single Dose, 1 day Drug: Placebo Oral Solution, Oral, 0 mg, Single Dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 1200 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 2000 mg, Single Dose, 1 day
Active Comparator: Arm 6 (BMS-813160 or placebo)	Drug: BMS-813160 Oral Solution, Oral, 5 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 20 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 60 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 150 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 300 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 600 mg, Single Dose, 1 day Drug: Placebo Oral Solution, Oral, 0 mg, Single Dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 1200 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 2000 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: BMS-813160 Oral Solution, Oral, 5 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 20 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 60 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 150 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 300 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 600 mg, Single Dose, 1 day Drug: Placebo Oral Solution, Oral, 0 mg, Single Dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 1200 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 2000 mg, Single Dose, 1 day
Active Comparator: Arm 9 (BMS-813160 or placebo)	Drug: BMS-813160 Oral Solution, Oral, 5 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 20 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 60 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 150 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 300 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 600 mg, Single Dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 1200 mg, Single dose, 1 day Drug: BMS-813160 Oral Solution, Oral, 2000 mg, Single Dose, 1 day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety will be assessed by clinical laboratory results, ECGs, vital signs, and reported adverse events Time Frame: Dosing through Day 5	Dosing through Day 5

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics of BMS-813160 Time Frame: 9 times after dosing	9 times after dosing
Pharmacodynamics (Plasma MCP-1) Time Frame: 9 times post dose	9 times post dose
Pharmacodynamics (Circulating monocytes) Time Frame: 5 times post dose	5 times post dose
Pharmacodynamics (CCR5 phosphorylation and internalization in whole blood) Time Frame: 5 times post-dose	5 times post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

January 12, 2010

First Submitted That Met QC Criteria

January 12, 2010

First Posted (Estimate)

January 14, 2010

Study Record Updates

Last Update Posted (Estimate)

February 11, 2011

Last Update Submitted That Met QC Criteria

February 10, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

CV202-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Single Ascending Dose (BMS-813160) Study

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

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Accelerated Intimal Hyperplasia

Clinical Trials on BMS-813160

Search Similar Trials

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