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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

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

Treatments: Drug: BMS-986231

Study type: Interventional

Funder types: Industry

Identifiers

NCT03332186

CV013-025

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 18 to 70 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:

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 4 patient groups

Mild Renal Impairment

Experimental group

Description:

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

Treatment:

Drug: BMS-986231

Moderate renal impairment

Experimental group

Description:

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

Treatment:

Drug: BMS-986231

Severe renal impairment

Experimental group

Description:

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

Treatment:

Drug: BMS-986231

Normal renal function

Experimental group

Description:

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

Treatment:

Drug: BMS-986231