A Study of Experimental Medication BMS-986231 in Patients With Different Levels of Kidney Function

A Phase 1, Open-Label, Parallel Group, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986231 in Subjects With Varying Degrees of Renal Function

The purpose of this study is to investigate experimental medication BMS-986231 in patients with different levels of kidney function.

Study Overview

• Status: Completed
• Conditions: Renal Failure; Congestive Heart Failure; Kidney Failure; Cardiac Failure; Myocardial Failure
• Intervention / Treatment: Drug: BMS-986231

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Czechia
  • Praha 7, Czechia, 170 00
    • Local Institution
• Poland
  • Grodzisk Mazowiecki, Poland, 05-825
    • Samodzielny Publiczny Secjalistyczny Szpital Zachodni im. sw. Jana Pawla II
  • Krakow, Poland, 31-559
    • Specjalistyczne Centrum Medyczne Panacea Poznan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Inclusion Criteria:

• Body weight ≥ 45 kg and ≤ 120 kg
• BMI ≥ 18 kg/m^2 and ≤ 35 kg/m^2
• Heart rate ≥ 50 bpm and < 95 bpm
• Stable renal impairment, defined as no clinically significant change in disease status, as documented by the subject's most recent eGFR assessment
• No changes in medication within 30 days prior to study drug administration

Exclusion Criteria:

• Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests
• History of chronic headaches, defined as occurring 15 days or more a month, over the previous 3 months
• History of headaches related to caffeine withdrawal
• History of migraine or cluster headaches
• Patients requiring dialysis will not be enrolled in this study

Other protocol defined inclusion/exclusion criteria could apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mild Renal Impairment; Mild renal impairment defined as eGFR 60 to <90 mL/min/1.73 m^2	Drug: BMS-986231; Intravenous infusion administration
Experimental: Moderate renal impairment; Moderate renal impairment defined as eGFR 30 to <60 mL/min/1.73 m^2	Drug: BMS-986231; Intravenous infusion administration
Experimental: Severe renal impairment; Severe renal impairment defined as eGFR <30 mL/min/1.73 m^2, not requiring dialysis	Drug: BMS-986231; Intravenous infusion administration
Experimental: Normal renal function; Normal renal function defined as eGFR ≥90 mL/min/1.73 m^2	Drug: BMS-986231; Intravenous infusion administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma concentration (Cmax) derived from plasma concentration	11 days
Area under the concentration-time curve from time 0 extrapolated to infinity [AUC(0-inf)] derived from plasma concentration	11 days
Metabolite ratio determined using AUC0-inf for metabolite/AUC0-inf [MRAUC(0-inf)] derived from plasma concentration	11 days
Clearance (CL) derived from plasma concentration	11 days
Renal clearance (CLR) derived from urine concentration	11 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of adverse events (AE)	Up to 31 days
Number of serious adverse events (SAE)	Up to 31 days
Terminal elimination half-life (t1/2)	Up to 36 hours
Time of maximum observed plasma concentration (Tmax)	Up to 36 hours
AUC up to time t, where t is the last time point with concentrations above the lower limit of quantitation (AUCt)	Up to 36 hours
Terminal elimination phase rate constant (λz)	Up to 36 hours
Volume of distribution during terminal phase (Vz)	Up to 36 hours
Fraction of administered drug excreted into urine (Fe)	Up to 36 hours
Cumulative amount excreted from time 0 to the time of the last quantifiable sample (Aelast)	Up to 36 hours

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2018
• Primary Completion (Actual): October 22, 2018
• Study Completion (Actual): October 22, 2018

Study Registration Dates

• First Submitted: November 2, 2017
• First Submitted That Met QC Criteria: November 2, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): September 11, 2019
• Last Update Submitted That Met QC Criteria: September 10, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Heart Failure; Renal Insufficiency
• Other Study ID Numbers: CV013-025

Drug and device information, study documents

• 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