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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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03890770
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Renal Impairment Healthy Volunteer Drug: BMS-986165 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 13, 2019
Actual Primary Completion Date : February 7, 2020
Actual Study Completion Date : February 13, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Normal renal function
Single dose
Drug: BMS-986165
Oral administration

Experimental: Mild renal disease
Single dose
Drug: BMS-986165
Oral administration

Experimental: Moderate renal failure
Single dose
Drug: BMS-986165
Oral administration

Experimental: Severe renal failure
Single dose
Drug: BMS-986165
Oral administration

Experimental: End-stage renal disease requiring dialysis
Two single doses administered with washout
Drug: BMS-986165
Oral administration




Primary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) [ Time Frame: Approximately 9 days ]
  2. 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 ]
  3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] [ Time Frame: Approximately 9 days ]

Secondary Outcome Measures :
  1. Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation [ Time Frame: Approximately 45 days ]
  2. Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations [ Time Frame: Approximately 45 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890770


Locations
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United States, Florida
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
Czechia
Pharmaceutical Research Associates CZ, s.r.o
Praha 7, Czechia, 170 00
Hungary
Szent Imre Egyetemi Oktatokorhaz
Budapest, Hungary, 1115
Kenezy Gyula Korhaz es Rendelointezet
Debrecen, Hungary, 4043
Poland
Samodzielny Publiczny Secjalistyczny Szpital Zachodni im. sw. Jana Pawla II
Grodzisk Mazowiecki, Poland, 05-825
Specjalistyczne Centrum Medyczne Chirurgii Maloinwazyjnej SCM
Krakow, Poland, 31-559
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03890770    
Other Study ID Numbers: IM011-061
2018-002533-38 ( EudraCT Number )
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020

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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
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
BMS-986165
Dermatologic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action