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COMPLETEDPHASE1

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.

An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of BMS-986165 in Participants With Normal Renal Function and Participants With Mild, Moderate, and Severe Renal Impairment and in Participants With End-Stage Renal Disease (ESRD) on Hemodialysis

NCT03890770•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
•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

Locations (6)

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

Key Dates

Start Date

April 4, 2019

Primary Completion Date

February 7, 2020

Completion Date

February 13, 2020

Last Updated

March 12, 2021

Enrollment

ACTUAL participants

Conditions

Renal ImpairmentHealthy Volunteer

Interventions

BMS-986165

DRUG

Collection of Data and Samples From Healthy Donors for Use in Translational Research

NCT00090662

Healthy Volunteer

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RECRUITINGPHASE1

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Healthy Volunteers (HV)Parkinson's Disease (PD)

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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.

Inclusion Criteria

Exclusion Criteria

Collection of Data and Samples From Healthy Donors for Use in Translational Research

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

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