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.

Completed · Phase 1

Conditions studied: Renal Impairment, Healthy Volunteer

In brief

The purpose of this study is to investigate BMS-986165 in participants with different levels of kidney function.

Key facts

Study ID

NCT03890770

Run by

Bristol-Myers Squibb

People needed

44

Starts

2019-04-04

Expected to finish

2020-02-13

Last updated by the study team

2021-03-12

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Orlando Clinical Research Center — Orlando, Florida, United States
• Pharmaceutical Research Associates CZ, s.r.o — Prague, Czechia
• Szent Imre Egyetemi Oktatokorhaz — Budapest, Hungary
• Kenezy Gyula Korhaz es Rendelointezet — Debrecen, Hungary
• Samodzielny Publiczny Secjalistyczny Szpital Zachodni im. sw. Jana Pawla II — Grodzisk Mazowiecki, Poland
• Specjalistyczne Centrum Medyczne Chirurgii Maloinwazyjnej SCM — Krakow, Poland

Full record on ClinicalTrials.gov

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