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

Cardiac Failure Clinical Trial

Official title:

A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of BMS-986224 in Participants With Varying Degrees of Renal Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03634969
• Other study ID #: CV016-010
• Status: Completed
• Phase: Phase 1
• Start date: August 14, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: February 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Failure
• Heart Failure
• Myocardial Failure

Intervention

Drug:
• BMS-986224
Specified dose on specified days

Locations

Country	Name	City	State
United States	Clinical Pharmacology of Miami	Miami	Florida
United States	Orlando Clinical Research Center	Orlando	Florida
United States	Prism Research	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) of BMS-986224		Up to 11 days
Primary	Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986224		Up to 11 days
Primary	Area under the plasma concentration-time curve from time zero to 72 h post dose [AUC(0-72)] of BMS-986224		Up to 11 days
Primary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986224		Up to 11 days
Primary	Time of maximum observed plasma concentration (Tmax) of BMS-986224		Up to 11 days
Primary	Terminal elimination half-life (T-HALF) of BMS-986224 derived from plasma concentration		Up to 11 days
Primary	Fraction of unbound drug in plasma (fu) of BMS-986224		Up to 11 days
Primary	Apparent oral clearance (CL/F) of BMS-986224 derived from plasma concentration		Up to 11 days
Primary	Apparent volume of distribution (Vz/F) of BMS-986224 derived from plasma concentration		Up to 11 days
Primary	Cumulative amount of unchanged drug excreted into the urine at a given time (Aet) of BMS-986224	Part 1 only	7 days
Primary	Fraction of dose excreted in urine (Fe%) of BMS-986224	Part 1 only	7 days
Primary	Renal clearance of BMS-986224 derived from urine concentration	Part 1 only	7 days
Secondary	Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation		Up to 41 days
Secondary	Maximum observed plasma concentration (Cmax) of metabolite		Up to 11 days
Secondary	Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of metabolite		Up to 11 days
Secondary	Area under the plasma concentration-time curve from time zero to 72 h post dose [AUC(0-72)] of metabolite		Up to 11 days
Secondary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of metabolite		Up to 11 days
Secondary	Time of maximum observed plasma concentration (Tmax) of metabolite		Up to 11 days
Secondary	Terminal elimination half-life (T-HALF) of metabolite derived from plasma concentration		Up to 11 days
Secondary	Metabolite-to-parent (MR) ratio for cMax		Up to 11 days
Secondary	Metabolite-to-parent (MR) ratio for AUC(0-T)		Up to 11 days
Secondary	Metabolite-to-parent (MR) ratio for AUC(0-72)		Up to 11 days
Secondary	Metabolite-to-parent (MR) ratio for AUC(INF)		Up to 11 days
Secondary	Number of clinically significant changes in vital signs, ECGs, physical examinations, or clinical laboratory tests		Up to 11 days

External Links

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