Healthy Participants
Conditions
Brief summary
Assess the absolute bioavailability of a tablet formulation of BMS-986205 following simultaneous oral administration of BMS-986205 and intravenous infusion of \[13C\]BMS-986205 solution for intravenous administration in healthy participants.
Interventions
DRUGBMS-986205
Specified Dose on Specified Days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index (BMI) 18.0 to 32.0 kg/m2, inclusive * Must have normal renal function demonstrated by an estimated glomerular filtration rate, calculated by Chronic Kidney Disease Epidemiology Collaboration formula * Women must not be of childbearing potential (cannot become pregnant)
Exclusion criteria
* Women who are of childbearing potential or breastfeeding * Any significant acute or chronic medical illness * Active tuberculosis (TB) requiring treatment or documented latent TB at screening Other protocol defined inclusion /
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute oral bioavailability (F) | Up to 15 days | Measured by plasma concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of serious adverse events (SAEs) | Up to 15 days | Safety and tolerability as measured by incidence of SAEs |
| Occurrence of adverse events (AEs) leading to discontinuation | Up to 15 days | Safety and tolerability as measured by incidence of AEs leading to discontinuation |
| Number of participants with vital sign measurement abnormalities | Up to 15 days | — |
| Occurrence of adverse events (AEs) | Up to 15 days | Safety and tolerability as measured by incidence of AEs |
| Number of participants with physical examination abnormalities | Up to 15 days | — |
| Number of participants with clinical laboratory test abnormalities | Up to 15 days | — |
| Number of participants with electrocardiogram abnormalities | Up to 15 days | — |
Countries
United Kingdom
Outcome results
None listed