An Investigational Study to Evaluate Experimental Medication BMS-986224 in Renally Impaired Participants

Bristol-Myers Squibb50 enrolled

Overview

The purpose of this study is to investigate the experimental medication BMS-986224 in participants with varying levels of renal function.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cardiac Failure Myocardial Failure

Interventions

BMS-986224DRUG

Specified dose on specified days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * BMI ≥18 and ≤ 35kg/m2 * Systolic blood pressure \>100 mmHg Exclusion Criteria: * Women of childbearing potential or women who are currently pregnant * Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the volunteer * Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption Other protocol defined inclusion/exclusion criteria could apply

Locations (3)

Clinical Pharmacology of Miami

Miami, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

Prism Research

Saint Paul, Minnesota, United States

Outcomes

Primary Outcomes

Maximum observed plasma concentration (Cmax) of BMS-986224

Time frame: Up to 11 days

Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986224

Time frame: Up to 11 days

Area under the plasma concentration-time curve from time zero to 72 h post dose [AUC(0-72)] of BMS-986224

Time frame: Up to 11 days

Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986224

Time frame: Up to 11 days

Time of maximum observed plasma concentration (Tmax) of BMS-986224

Time frame: Up to 11 days

Terminal elimination half-life (T-HALF) of BMS-986224 derived from plasma concentration

Time frame: Up to 11 days

Fraction of unbound drug in plasma (fu) of BMS-986224

Time frame: Up to 11 days

Apparent oral clearance (CL/F) of BMS-986224 derived from plasma concentration

Time frame: Up to 11 days

Apparent volume of distribution (Vz/F) of BMS-986224 derived from plasma concentration

Time frame: Up to 11 days

Cumulative amount of unchanged drug excreted into the urine at a given time (Aet) of BMS-986224

Part 1 only

Time frame: 7 days

Fraction of dose excreted in urine (Fe%) of BMS-986224

Data from ClinicalTrials.gov

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Secondary Outcomes

Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation

Time frame: Up to 41 days

Maximum observed plasma concentration (Cmax) of metabolite

Time frame: Up to 11 days

Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of metabolite

Time frame: Up to 11 days

Area under the plasma concentration-time curve from time zero to 72 h post dose [AUC(0-72)] of metabolite

Time frame: Up to 11 days

Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of metabolite

Time frame: Up to 11 days

Time of maximum observed plasma concentration (Tmax) of metabolite

Time frame: Up to 11 days

Terminal elimination half-life (T-HALF) of metabolite derived from plasma concentration

Time frame: Up to 11 days

Metabolite-to-parent (MR) ratio for cMax

Time frame: Up to 11 days

Metabolite-to-parent (MR) ratio for AUC(0-T)

Time frame: Up to 11 days

Metabolite-to-parent (MR) ratio for AUC(0-72)

Time frame: Up to 11 days

Metabolite-to-parent (MR) ratio for AUC(INF)

Time frame: Up to 11 days

Number of clinically significant changes in vital signs, ECGs, physical examinations, or clinical laboratory tests

Time frame: Up to 11 days