Back to resultsA Study to Assess the Safety of Experimental Medication BMS986165 in Participants With Normal Kidney Function and Participants With Mild to End-Stage Kidney Disease.
Primary Purpose
Renal Impairment, Healthy Volunteer
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BMS-986165
Sponsored by
About this trial
This is an interventional treatment trial for Renal Impairment
Eligibility Criteria
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
Sites / Locations
- Orlando Clinical Research Center
- Pharmaceutical Research Associates CZ, s.r.o
- Szent Imre Egyetemi Oktatokorhaz
- Kenezy Gyula Korhaz es Rendelointezet
- Samodzielny Publiczny Secjalistyczny Szpital Zachodni im. sw. Jana Pawla II
- Specjalistyczne Centrum Medyczne Chirurgii Maloinwazyjnej SCM
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Normal renal function
Mild renal disease
Moderate renal failure
Severe renal failure
End-stage renal disease requiring dialysis
Arm Description
Single dose
Single dose
Single dose
Single dose
Two single doses administered with washout
Outcomes
Primary Outcome Measures
Maximum observed plasma concentration (Cmax)
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Secondary Outcome Measures
Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation
Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03890770
Brief Title
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.
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 4, 2019 (Actual)
Primary Completion Date
February 7, 2020 (Actual)
Study Completion Date
February 13, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
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
5. Study Description
Brief Summary
The purpose of this study is to investigate BMS-986165 in participants with different levels of kidney function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Impairment, Healthy Volunteer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal renal function
Arm Type
Experimental
Arm Description
Single dose
Arm Title
Mild renal disease
Arm Type
Experimental
Arm Description
Single dose
Arm Title
Moderate renal failure
Arm Type
Experimental
Arm Description
Single dose
Arm Title
Severe renal failure
Arm Type
Experimental
Arm Description
Single dose
Arm Title
End-stage renal disease requiring dialysis
Arm Type
Experimental
Arm Description
Two single doses administered with washout
Intervention Type
Drug
Intervention Name(s)
BMS-986165
Intervention Description
Oral administration
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax)
Time Frame
Approximately 9 days
Title
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
Title
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Time Frame
Approximately 9 days
Secondary Outcome Measure Information:
Title
Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation
Time Frame
Approximately 45 days
Title
Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations
Time Frame
Approximately 45 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
Pharmaceutical Research Associates CZ, s.r.o
City
Praha 7
ZIP/Postal Code
170 00
Country
Czechia
Facility Name
Szent Imre Egyetemi Oktatokorhaz
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
Facility Name
Kenezy Gyula Korhaz es Rendelointezet
City
Debrecen
ZIP/Postal Code
4043
Country
Hungary
Facility Name
Samodzielny Publiczny Secjalistyczny Szpital Zachodni im. sw. Jana Pawla II
City
Grodzisk Mazowiecki
ZIP/Postal Code
05-825
Country
Poland
Facility Name
Specjalistyczne Centrum Medyczne Chirurgii Maloinwazyjnej SCM
City
Krakow
ZIP/Postal Code
31-559
Country
Poland
12. IPD Sharing Statement
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
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.
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