Accelerated Intimal Hyperplasia
Conditions
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
Interventions
DRUGBMS-813160
Oral Solution, Oral, 5 mg, Single dose, 1 day
DRUG[14C] BMS-813160
Oral Solution, Oral, 150 mg, Single Dose, 1 day
DRUGPlacebo
Oral Solution, Oral, 0 mg, Single Dose, 1 day
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety will be assessed by clinical laboratory results, ECGs, vital signs, and reported adverse events | Dosing through Day 5 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed