Healthy Volunteers, Liver Dysfunction
Conditions
Brief summary
The purpose of this study is to investigate BMS-986165 in participants with different levels of liver function.
Interventions
DRUGBMS-986165
Oral administration
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
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: * Body mass index of 18.0 to 38.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening * Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) \> 80 mL/min/1.73 m2 for participants
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 * History or clinical evidence of acute or chronic bacterial infection (eg, pneumonia, septicemia) within 3 months prior to screening * Have a history of cancer (malignancy) with the following exceptions: (1) participants with adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix may participate in the trial; (2) participants with other malignancies who 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 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 44 days |
| Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations | Approximately 44 days |
Countries
Czechia, Hungary, Slovakia
Outcome results
None listed