Single Ascending Dose (BMS-813160) Study
Phase 1
Completed
- Conditions
- Accelerated Intimal Hyperplasia
- Interventions
- Registration Number
- NCT01049165
- Lead Sponsor
- Bristol-Myers Squibb
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 3 (BMS-813160 or placebo) Placebo - Arm 9 (BMS-813160 or placebo) BMS-813160 - Arm 4 (BMS-813160 or placebo) Placebo - Arm 5 (BMS-813160 or placebo) Placebo - Arm 6 (BMS-813160 or placebo) Placebo - Arm 7 [14C] BMS-813160 [14C] BMS-813160 - Arm 8 (BMS-813160 or placebo) Placebo - Arm 1 (BMS-813160 or placebo) BMS-813160 - Arm 1 (BMS-813160 or placebo) Placebo - Arm 2 (BMS-813160 or placebo) Placebo - Arm 4 (BMS-813160 or placebo) BMS-813160 - Arm 6 (BMS-813160 or placebo) BMS-813160 - Arm 8 (BMS-813160 or placebo) BMS-813160 - Arm 2 (BMS-813160 or placebo) BMS-813160 - Arm 3 (BMS-813160 or placebo) BMS-813160 - Arm 5 (BMS-813160 or placebo) BMS-813160 -
- Primary Outcome Measures
Name Time Method Safety will be assessed by clinical laboratory results, ECGs, vital signs, and reported adverse events Dosing through Day 5
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Covance Clinical Research Unit, Inc.
🇺🇸Madison, Wisconsin, United States