Single Ascending Dose (BMS-813160) Study

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT01049165

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

7.8

Patients Per Site Per Month

Study Details

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

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

Study Design

Study Type:

Interventional

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 :

Feb 1, 2010

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Nov 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Safety will be assessed by clinical laboratory results, ECGs, vital signs, and reported adverse events [Dosing through Day 5]

Secondary Outcome Measures

Pharmacokinetics of BMS-813160 [9 times after dosing]
Pharmacodynamics (Plasma MCP-1) [9 times post dose]
Pharmacodynamics (Circulating monocytes) [5 times post dose]
Pharmacodynamics (CCR5 phosphorylation and internalization in whole blood) [5 times post-dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01049165

Other Study ID Numbers:

CV202-001

First Posted:

Jan 14, 2010

Last Update Posted:

Feb 11, 2011

Last Verified:

Feb 1, 2011

Additional relevant MeSH terms:

Hyperplasia

Study Results

No Results Posted as of Feb 11, 2011