A Study to Evaluate the Pharmacokinetics (Drug Levels and Metabolism), Safety, and Tolerability of BMS-986259 in Participants With Various Levels of Kidney Function

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Renal Failure

Treatments: Drug: BMS-986259

Study type: Interventional

Funder types: Industry

Identifiers

NCT04237831

CV019-008

Details and patient eligibility

About

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

Full description

Recruitment temporarily on hold due to COVID-19

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

30 participants in 4 patient groups

Arm A: Normal Renal Function

Experimental group

Treatment:

Drug: BMS-986259

Arm B: Mild Renal Impairment

Experimental group

Treatment:

Drug: BMS-986259

Arm C: Moderate Renal Impairment

Experimental group

Treatment:

Drug: BMS-986259

Arm D: Severe Renal Impairment

Experimental group

Treatment:

Drug: BMS-986259