Healthy Volunteer, Renal Impairment
Conditions
Brief summary
The purpose of this study is to investigate BMS-986165 in participants with different levels of kidney function.
Interventions
DRUGBMS-986165
Oral administration
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Participants must be judged to be in good health in the opinion of the investigator OR participant has a stable disease (eg, hypertension, hyperlipidemia, diabetes mellitus, hyperthyreosis) under medical control (ie, no changes in medication within 30 days prior to study drug administration) * Stable renal impairment, defined as no clinically significant change in disease status, as documented by the participant's most recent eGFR assessment; eGFR must not vary more than 30% from screening to Day -1 to confirm stable renal function, and the renal impairment must be expected by the investigator not to change significantly during the next 3 months * Body mass index of 18.0 to 38.0 kg/m2, inclusive, and weight ≥50 kg, at screening
Exclusion criteria
* Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the participant * Have a history of cancer (malignancy) with the following exceptions: (1) subjects with adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix may participate in the trial; (2) subjects with other malignancies that have been successfully treated ≥10 years prior to the screening visit where, in the judgment of both the investigator and treating physician, appropriate follow-up has revealed no evidence of recurrence from the time of treatment through the time of the screening visit * History or clinical evidence of acute or chronic bacterial infection (eg, pneumonia, septicemia) within 3 months prior to screening Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration (Cmax) | Approximately 9 days |
| Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] | Approximately 9 days |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] | Approximately 9 days |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation | Approximately 45 days |
| Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations | Approximately 45 days |
Countries
Czechia, Hungary, Poland, United States
Outcome results
None listed