A Study to Evaluate the Pharmacokinetics (Drug Levels and Metabolism), Safety, and Tolerability of BMS-986259 in Participants With Various Levels of Kidney Function
NCT ID: NCT04237831
Last Updated: 2021-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2020-02-26
2021-07-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Arm A: Normal Renal Function
BMS-986259
Specified Dose on Specified Days
Arm B: Mild Renal Impairment
BMS-986259
Specified Dose on Specified Days
Arm C: Moderate Renal Impairment
BMS-986259
Specified Dose on Specified Days
Arm D: Severe Renal Impairment
BMS-986259
Specified Dose on Specified Days
Interventions
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BMS-986259
Specified Dose on Specified Days
Eligibility Criteria
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Inclusion Criteria
* No change in medications to control Chronic Kidney Disease (CKD) for at least 2 weeks prior to dosing, and if possible, during confinement in the clinical research unit (CRU), except those cleared by the investigator and Medical Monitor.
* Participants with normal renal function at screening, based upon the opinion of the investigator's medical evaluation.
* Medically well-controlled disorders (eg, stable chronic asthma, allergy) are permitted if the treatment for the disease does not interfere with the study.
* Women and men must use highly effective methods of contraception for the duration of treatment
Exclusion Criteria
* Positive results for drugs abuse in urine/saliva
* Participants undergoing any method of dialysis (eg, hemodialysis, peritoneal dialysis) within the last 3 months or with anticipated need for dialysis during the study
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory assessments beyond what is consistent with the target population
* Known previous exposure to BMS-986259
18 Years
80 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Clinical Pharmacology of Miami
Miami, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Prism Clinical Research
Saint Paul, Minnesota, United States
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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CV019-008
Identifier Type: -
Identifier Source: org_study_id
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