Thrombosis
Conditions
Brief summary
Assess the pharmacokinetics (fasting and fed), safety, and tolerability of BMS-986177 following oral dosing of Form A and Form B
Interventions
DRUGBMS-986177
Form A
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index 18.0 to 32.0 kg/m2, inclusive * Women must not be of childbearing potential (cannot become pregnant)
Exclusion criteria
* Any significant acute or chronic medical illness * Head injury in the last 2 years * History of bleeding disorder including rectal bleeding (ie, hemorrhoids), spontaneous nosebleeds, etc. Other protocol defined inclusion /
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to 3 days | Measured by plasma concentration |
| AUC from time zero to time of last quantifiable concentration (AUC(0-T)) | Up to 3 days | Measured by plasma concentration |
| AUC from time zero extrapolated to infinite time (AUC(INF)) | Up to 3 days | Measured by plasma concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with physical examination abnormalities | Up to 12 days | — |
| Incidence of Adverse Events (AEs) | Up to 12 days | Safety and tolerability as measured by incidence of AEs |
| Number of participants with clinical laboratory abnormalities | Up to 12 days | — |
| Incidence of Serious Adverse Events (SAEs) | Up to 30 days | Safety and tolerability as measured by incidence of SAEs |
| Number of participants with electrocardiogram abnormalities | Up to 12 days | — |
Countries
United Kingdom
Outcome results
None listed