Healthy
Conditions
Keywords
Subjects
Brief summary
This is the first clinical study with the BMS-986147 compound in healthy subjects. The purpose of this study is to guide the dose range and dose frequency for future studies with BMS-986147 and will provide guidelines for selection of a potentially effective dose in patients.
Interventions
DRUGBMS-986147
DRUGPlacebo matching BMS-986147
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Healthy men and women, ages 18 to 45 years * Subjects must not have clinically significant deviation from normal: medical history, physical examination, ECGs and laboratory evaluations * Women of child bearing potential are eligible for enrollment. * Women must have a negative pregnancy test
Exclusion criteria
* Evidence of organ dysfunction * Any significant acute or chronic medical illness * Inability to: tolerate oral medications, be venipunctured
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of single oral dose of BMS-986147 based on incidence of AEs, serious AEs, AEs leading to discontinuation, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, and physical examinations | Up to 30 days post last dose of study drug | Adverse event (AE) |
| Safety and tolerability of multiple oral dose of BMS-986147 based on incidence of AEs, serious AEs, AEs leading to discontinuation, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, and physical examinations | Up to 30 days post last dose of study drug | — |
Countries
United States
Outcome results
None listed