Clinical trial NCT04237831: A Study to Evaluate the Pharmacokinetics (Drug Levels and Metabolism), Safety, and Tolerability of BMS-986259 in Participants With Various Levels of Kidney Function
Official title: A Phase 1, Open-Label, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986259 in Participants With Varying Degrees of Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Failure
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-01-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: A study to evaluate the drug effect, safety, and tolerability of BMS-986259 in participants with different levels of kidney function

Detailed description: Recruitment temporarily on hold due to COVID-19

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

Inclusion Criteria:

* Participant must have renal impairment, as defined by eGFR at screening using the Chronic Kidney Disease Epidemiology (CKD-EPI) equation
* 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:

* History of any significant drug allergy or drug-related Serious Adverse Events (SAE) (such as anaphylaxis or hepatotoxicity)
* 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

Other inclusion/exclusion criteria apply

Primary outcomes:
measure: Maximum plasma Concentration (Cmax) of BMS-986259 in Blood serum
timeFrame: Day 1 and Day 8
measure: Time to reach maximum concentration in plasma (Tmax) of BMS-986259 in blood serum
timeFrame: Day 1 and Day 8
measure: Area under the concentration- time curve over the dosing interval of BMS-986259 in blood serum - AUC(TAU)
timeFrame: Day 1 and Day 8
measure: Concentration of BMS-986259 in blood serum at 24 hours (C24)
timeFrame: Day 1 and Day 8
measure: Area under the concentration-time curve of BMS-986259 from time 0 (dosing) to the time of the last quantifiable - AUC(0-T)
timeFrame: Day 8
measure: Accumulation ratio in the maximum plasma concentration of BMS-986259 in blood serum -AR(Cmax)
timeFrame: Day 8
measure: Accumulation ratio of Area under the concentration-time curve in BMS-986259 over the dosing interval -AR (AUC [TAU])
timeFrame: Day 8
measure: Accumulation ratio concentration of BMS-986259 at 24 hours- AR(C24)
timeFrame: Day 8
measure: Terminal elimination half-life of BMS-986259 (T-HALF)
timeFrame: Day 8
measure: Apparent total clearance of BMS-986259 at steady-state (CLss/F)
timeFrame: Day 8
measure: Apparent volume of distribution of BMS-986259 at terminal phase at steady-state (Vss/F)
timeFrame: Day 8
Secondary outcomes:
measure: Incidence of Non serious Adverse Events (AEs)
timeFrame: Up to 4 months
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to 4 months
measure: Incidence of AEs leading to discontinuation
timeFrame: Up to 4 months
measure: Number of clinically significant changes in vital signs
timeFrame: Up to 4 months
measure: Number in clinically significant changes in Electrocardiogram (ECG)
timeFrame: Up to 4 months
measure: Number of clinically significant changes in physical examinations
timeFrame: Up to 4 months
measure: Number of clinically significant changes in clinical laboratory tests
timeFrame: Up to 4 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Saint Paul
country: United States
facility: Prism Clinical Research
state: Minnesota
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: