Single Ascending Dose (BMS-813160) Study

This study has been completed.

Sponsor:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT01049165

First received: January 12, 2010

Last updated: February 10, 2011

Last verified: February 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

January 12, 2010

Last Updated Date

February 10, 2011

Start Date ^ICMJE

February 2010

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety will be assessed by clinical laboratory results, ECGs, vital signs, and reported adverse events [ Time Frame: Dosing through Day 5 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01049165 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pharmacokinetics of BMS-813160 [ Time Frame: 9 times after dosing ] [ Designated as safety issue: No ]
Pharmacodynamics (Plasma MCP-1) [ Time Frame: 9 times post dose ] [ Designated as safety issue: No ]
Pharmacodynamics (Circulating monocytes) [ Time Frame: 5 times post dose ] [ Designated as safety issue: No ]
Pharmacodynamics (CCR5 phosphorylation and internalization in whole blood) [ Time Frame: 5 times post-dose ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Single Ascending Dose (BMS-813160) Study

Official Title ^ICMJE

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

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science

Condition ^ICMJE

Accelerated Intimal Hyperplasia

Intervention ^ICMJE

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: [14C] BMS-813160
Oral Solution, Oral, 150 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

Study Arm (s)

Active Comparator: Arm 1 (BMS-813160 or placebo)
Interventions:
- Drug: BMS-813160
- Drug: Placebo
Active Comparator: Arm 2 (BMS-813160 or placebo)
Interventions:
- Drug: BMS-813160
- Drug: Placebo
Active Comparator: Arm 3 (BMS-813160 or placebo)
Interventions:
- Drug: BMS-813160
- Drug: Placebo
Active Comparator: Arm 4 (BMS-813160 or placebo)
Interventions:
- Drug: BMS-813160
- Drug: Placebo
Active Comparator: Arm 5 (BMS-813160 or placebo)
Interventions:
- Drug: BMS-813160
- Drug: Placebo
Active Comparator: Arm 6 (BMS-813160 or placebo)
Interventions:
- Drug: BMS-813160
- Drug: Placebo
Active Comparator: Arm 7 [14C] BMS-813160
Intervention: Drug: [14C] BMS-813160
Active Comparator: Arm 8 (BMS-813160 or placebo)
Interventions:
- Drug: Placebo
- Drug: BMS-813160
Active Comparator: Arm 9 (BMS-813160 or placebo)
Intervention: Drug: BMS-813160

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2010

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01049165

Other Study ID Numbers ^ICMJE

CV202-001

Has Data Monitoring Committee

Responsible Party

Study Director, Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

February 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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