Single Ascending Dose (BMS-813160) Study

Accelerated Intimal Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01049165
• Other study ID #: CV202-001
• Status: Completed
• Phase: Phase 1
• First received: January 12, 2010
• Last updated: February 10, 2011
• Start date: February 2010
• Est. completion date: November 2010

Study information

• Verified date: February 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Accelerated Intimal Hyperplasia
• Hyperplasia

Intervention

Drug:
• BMS-813160
Oral Solution, Oral, 5 mg, Single dose, 1 day
• BMS-813160
Oral Solution, Oral, 20 mg, Single dose, 1 day
• BMS-813160
Oral Solution, Oral, 60 mg, Single dose, 1 day
• BMS-813160
Oral Solution, Oral, 150 mg, Single dose, 1 day
• BMS-813160
Oral Solution, Oral, 300 mg, Single dose, 1 day
• BMS-813160
Oral Solution, Oral, 600 mg, Single Dose, 1 day
• [14C] BMS-813160
Oral Solution, Oral, 150 mg, Single Dose, 1 day
• Placebo
Oral Solution, Oral, 0 mg, Single Dose, 1 day
• BMS-813160
Oral Solution, Oral, 1200 mg, Single dose, 1 day
• BMS-813160
Oral Solution, Oral, 2000 mg, Single Dose, 1 day

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit, Inc.	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety will be assessed by clinical laboratory results, ECGs, vital signs, and reported adverse events		Dosing through Day 5	No
Secondary	Pharmacokinetics of BMS-813160		9 times after dosing	No
Secondary	Pharmacodynamics (Plasma MCP-1)		9 times post dose	No
Secondary	Pharmacodynamics (Circulating monocytes)		5 times post dose	No
Secondary	Pharmacodynamics (CCR5 phosphorylation and internalization in whole blood)		5 times post-dose	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form