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

Phase 1

Completed

• Conditions: Cardiac Failure; Myocardial Failure; Congestive Heart Failure; Kidney Failure; Renal Failure
• Interventions: Drug: BMS-986231

• Registration Number: NCT03332186
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-02
• Study First Submitted QC: 2017-11-02
• Study First Posted: 2017-11-06
• Study Start: 2018-03-15
• Primary Completion: 2018-10-22
• Study Completion: 2018-10-22
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moderate renal impairment	BMS-986231	Moderate renal impairment defined as eGFR 30 to \<60 mL/min/1.73 m\^2
Severe renal impairment	BMS-986231	Severe renal impairment defined as eGFR \<30 mL/min/1.73 m\^2, not requiring dialysis
Normal renal function	BMS-986231	Normal renal function defined as eGFR ≥90 mL/min/1.73 m\^2
Mild Renal Impairment	BMS-986231	Mild renal impairment defined as eGFR 60 to \<90 mL/min/1.73 m\^2

Primary Outcome Measures

Name	Time	Method
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
Renal clearance (CLR) derived from urine concentration	11 days
Maximum observed plasma concentration (Cmax) derived from plasma concentration	11 days
Clearance (CL) derived from plasma concentration	11 days

Secondary Outcome Measures

Name	Time	Method
Number of serious adverse events (SAE)	Up to 31 days
Terminal elimination phase rate constant (λz)	Up to 36 hours
Number of adverse events (AE)	Up to 31 days
Terminal elimination half-life (t1/2)	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
Time of maximum observed plasma concentration (Tmax)	Up to 36 hours
Cumulative amount excreted from time 0 to the time of the last quantifiable sample (Aelast)	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

Trial Locations

Locations (3)

Local Institution; 🇨🇿 Praha 7, Czechia

Samodzielny Publiczny Secjalistyczny Szpital Zachodni im. sw. Jana Pawla II; 🇵🇱 Grodzisk Mazowiecki, Poland

Specjalistyczne Centrum Medyczne Panacea Poznan; 🇵🇱 Krakow, Poland