- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03890770
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.
March 10, 2021 updated by: Bristol-Myers Squibb
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
The purpose of this study is to investigate BMS-986165 in participants with different levels of kidney function.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Praha 7, Czechia, 170 00
- Pharmaceutical Research Associates CZ, s.r.o
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Budapest, Hungary, 1115
- Szent Imre Egyetemi Oktatokorhaz
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Debrecen, Hungary, 4043
- Kenézy Gyula Kórház És Rendelőintézet
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Grodzisk Mazowiecki, Poland, 05-825
- Samodzielny Publiczny Secjalistyczny Szpital Zachodni im. sw. Jana Pawla II
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Krakow, Poland, 31-559
- Specjalistyczne Centrum Medyczne Chirurgii Maloinwazyjnej SCM
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Florida
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Orlando, Florida, United States, 32809
- Orlando Clinical Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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/exclusion criteria could apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Normal renal function
Single dose
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Oral administration
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Experimental: Mild renal disease
Single dose
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Oral administration
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Experimental: Moderate renal failure
Single dose
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Oral administration
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Experimental: Severe renal failure
Single dose
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Oral administration
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Experimental: End-stage renal disease requiring dialysis
Two single doses administered with washout
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Oral administration
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum observed plasma concentration (Cmax)
Time Frame: Approximately 9 days
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Approximately 9 days
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Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]
Time Frame: Approximately 9 days
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Approximately 9 days
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Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Time Frame: Approximately 9 days
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Approximately 9 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation
Time Frame: Approximately 45 days
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Approximately 45 days
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Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations
Time Frame: Approximately 45 days
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Approximately 45 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 4, 2019
Primary Completion (Actual)
February 7, 2020
Study Completion (Actual)
February 13, 2020
Study Registration Dates
First Submitted
March 25, 2019
First Submitted That Met QC Criteria
March 25, 2019
First Posted (Actual)
March 26, 2019
Study Record Updates
Last Update Posted (Actual)
March 12, 2021
Last Update Submitted That Met QC Criteria
March 10, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IM011-061
- 2018-002533-38 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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