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

NCT ID: NCT03332186

Last Updated: 2019-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-15
• Study Completion Date: 2018-10-22

Brief Summary

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

Conditions

Myocardial Failure; Cardiac Failure; Congestive Heart Failure; Kidney Failure; Renal Failure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mild Renal Impairment

Mild renal impairment defined as eGFR 60 to \<90 mL/min/1.73 m\^2

Group Type: EXPERIMENTAL

BMS-986231

Intervention Type: DRUG

Intravenous infusion administration

Moderate renal impairment

Moderate renal impairment defined as eGFR 30 to \<60 mL/min/1.73 m\^2

Group Type: EXPERIMENTAL

BMS-986231

Intervention Type: DRUG

Intravenous infusion administration

Severe renal impairment

Severe renal impairment defined as eGFR \<30 mL/min/1.73 m\^2, not requiring dialysis

Group Type: EXPERIMENTAL

BMS-986231

Intervention Type: DRUG

Intravenous infusion administration

Normal renal function

Normal renal function defined as eGFR ≥90 mL/min/1.73 m\^2

Group Type: EXPERIMENTAL

BMS-986231

Intervention Type: DRUG

Intravenous infusion administration

Interventions

BMS-986231

Intravenous infusion administration

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Local Institution

Prague, , Czechia

Samodzielny Publiczny Secjalistyczny Szpital Zachodni im. sw. Jana Pawla II

Grodzisk Mazowiecki, , Poland

Specjalistyczne Centrum Medyczne Panacea Poznan

Krakow, , Poland

Countries

Czechia; Poland

Related Links

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsstudyconnect.com/s/US/English/USenHome

BMS Clinical Trial Patient Recruiting

https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html

Investigator Inquiry Form

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

CV013-025

Identifier Type: -

Identifier Source: org_study_id