Thrombosis
Conditions
Brief summary
Assess the pharmacokinetics, safety, and tolerability of a single dose of BMS-986177 in participants with normal renal function and moderate to severe renal impairment.
Interventions
DRUGBMS-986177
Oral Suspension
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants in Groups B and C will be classified by renal function by eGRF at screening and confirmed on Day -1 * Participants in Group A will be healthy participants as determined by no significant deviations in normal medical and surgical history and assessments * Participants in Group A must have a body mass index of 18.0 to 32.0 kg/m2, inclusive * Females must be of non-childbearing potential
Exclusion criteria
* Participants in Groups B and C cannot have an indwelling catheter for hemodialysis * Participants in Groups B and C cannot have had, nor be waiting for, an organ transplant Other protocol defined inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to 5 days | Measured by plasma concentration |
| AUC from time zero to time of last quantifiable concentration (AUC (0-T)) | Up to 5 days | Summary measures of PK parameters |
| AUC from time zero extrapolated to infinite time (AUC (INF)) | Up to 5 days | Summary measures of PK parameters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in physical examination findings | Up to 5 days | Measured by investigator assessment |
| Incidence of Adverse Events (AEs) | Up to 5 days | Safety and tolerability as measured by incidence of AEs |
| Change from baseline in clinical laboratory test findings | Up to 5 days | Measured by investigator assessment |
| Incidence of Serious Adverse Events ( SAEs) | Up to 30 days | Safety and tolerability as measured by incidence of SAEs |
| Change from baseline in electrocardiogram findings | Up to 5 days | Measured by investigator assessment |
Countries
United States
Outcome results
None listed