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

Renal Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04237831
• Other study ID #: CV019-008
• Status: Completed
• Phase: Phase 1
• Start date: February 26, 2020
• Est. completion date: July 16, 2021

Study information

• Verified date: September 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Recruitment temporarily on hold due to COVID-19

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 16, 2021
• Est. primary completion date: July 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Renal Failure
• Renal Insufficiency

Intervention

Drug:
• BMS-986259
Specified Dose on Specified Days

Locations

Country	Name	City	State
United States	Clinical Pharmacology of Miami	Miami	Florida
United States	Orlando Clinical Research Center	Orlando	Florida
United States	Prism Clinical Research	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma Concentration (Cmax) of BMS-986259 in Blood serum		Day 1 and Day 8
Primary	Time to reach maximum concentration in plasma (Tmax) of BMS-986259 in blood serum		Day 1 and Day 8
Primary	Area under the concentration- time curve over the dosing interval of BMS-986259 in blood serum - AUC(TAU)		Day 1 and Day 8
Primary	Concentration of BMS-986259 in blood serum at 24 hours (C24)		Day 1 and Day 8
Primary	Area under the concentration-time curve of BMS-986259 from time 0 (dosing) to the time of the last quantifiable - AUC(0-T)		Day 8
Primary	Accumulation ratio in the maximum plasma concentration of BMS-986259 in blood serum -AR(Cmax)		Day 8
Primary	Accumulation ratio of Area under the concentration-time curve in BMS-986259 over the dosing interval -AR (AUC [TAU])		Day 8
Primary	Accumulation ratio concentration of BMS-986259 at 24 hours- AR(C24)		Day 8
Primary	Terminal elimination half-life of BMS-986259 (T-HALF)		Day 8
Primary	Apparent total clearance of BMS-986259 at steady-state (CLss/F)		Day 8
Primary	Apparent volume of distribution of BMS-986259 at terminal phase at steady-state (Vss/F)		Day 8
Secondary	Incidence of Non serious Adverse Events (AEs)		Up to 4 months
Secondary	Incidence of Serious Adverse Events (SAEs)		Up to 4 months
Secondary	Incidence of AEs leading to discontinuation		Up to 4 months
Secondary	Number of clinically significant changes in vital signs		Up to 4 months
Secondary	Number in clinically significant changes in Electrocardiogram (ECG)		Up to 4 months
Secondary	Number of clinically significant changes in physical examinations		Up to 4 months
Secondary	Number of clinically significant changes in clinical laboratory tests		Up to 4 months

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls