A Study to Assess the Safety of Experimental Medication BMS986165 in Participants With Normal Kidney Function and Participants With Mild to End-Stage Kidney Disease.
- Registration Number
- NCT03890770
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to investigate BMS-986165 in participants with different levels of kidney function.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
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
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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/exclusion criteria could apply
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description End-stage renal disease requiring dialysis BMS-986165 Two single doses administered with washout Moderate renal failure BMS-986165 Single dose Severe renal failure BMS-986165 Single dose Mild renal disease BMS-986165 Single dose Normal renal function BMS-986165 Single dose
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (6)
Orlando Clinical Research Center
🇺🇸Orlando, Florida, United States
Szent Imre Egyetemi Oktatokorhaz
🇭🇺Budapest, Hungary
Pharmaceutical Research Associates CZ, s.r.o
🇨🇿Praha 7, Czechia
Specjalistyczne Centrum Medyczne Chirurgii Maloinwazyjnej SCM
🇵🇱Krakow, Poland
Kenezy Gyula Korhaz es Rendelointezet
🇭🇺Debrecen, Hungary
Samodzielny Publiczny Secjalistyczny Szpital Zachodni im. sw. Jana Pawla II
🇵🇱Grodzisk Mazowiecki, Poland