An Investigational Study of Experimental Medication BMS-986231 Given in Participants With Different Levels of Liver Function

Congestive Heart Failure Clinical Trial

Official title:

A Phase 1, Open-Label, Parallel Group, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986231 in Participants With Varying Degrees of Hepatic Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03515980
• Other study ID #: CV013-026
• Secondary ID: 2017-004914-24
• Status: Completed
• Phase: Phase 1
• Start date: May 25, 2018
• Est. completion date: August 29, 2019

Study information

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

Clinical Trial Summary

This is an investigational study of experimental Medication BMS-986231 given to participants with weakened or damaged liver function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: August 29, 2019
• Est. primary completion date: August 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Body weight = 45 kg and = 120 kg and BMI = 18 kg/m2 and = 35 kg/m2

• Heart rate = 50 bpm and < 95 bpm

• Women of childbearing potential must have a negative urine or serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of study treatment

Exclusion Criteria:

• 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

• History of chronic headaches (defined as occurring 15 days or more a month, over the previous 3 months), headaches related to caffeine withdrawal (ie, coffee, soda, tea, energy drinks, etc.), or moderately severe to severe headaches

• History of migraine or cluster headaches

Other protocol defined inclusion/exclusion criteria could apply

Related Conditions & MeSH terms

• Cardiac Failure
• Congestive Heart Failure
• Heart Decompensation
• Heart Failure
• Hepatic Failure
• Hepatic Insufficiency
• Liver Diseases
• Liver Dysfunction
• Liver Failure
• Liver Insufficiency
• Myocardial Failure

Intervention

Drug:
• BMS-986231
Intravenous (IV) administration

Locations

Country	Name	City	State
Hungary	Semmelweis Egyetem Altalanos Orvostudomanyi Kar	Budapest
Hungary	Clinical Research Unit Hungary	Miskolc
Poland	BioVirtus Centrum Medyczne	Jozefow
Poland	KO-MED Centra Kliniczne Lublin	Lublin

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Hungary,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the concentration-time curve from time 0 extrapolated to infinity [AUC(INF)] derived from plasma concentration		Up to 2 days
Primary	AUC from time 0 up to time T, where T is the last time point with concentrations above the lower limit of quantitation [AUC(0-T)] derived from plasma concentration		Up to 2 days
Primary	Maximum plasma concentration (Cmax)		Up to 2 days
Secondary	Incidence of adverse events (AE)		Up to 33 days
Secondary	Incidence of serious adverse events (SAE)		Up to 33 days
Secondary	Incidence of Laboratory Test Result Abnormalities		Up to 11 days
Secondary	Clearance (CL) derived from plasma concentration		Up to 2 days
Secondary	Terminal elimination half-life (t1/2) derived from plasma concentration		Up to 2 days
Secondary	Time of maximum observed plasma concentration (Tmax)		Up to 2 days
Secondary	Terminal elimination phase rate constant (?z) derived from plasma concentration		Up to 2 days
Secondary	Volume of distribution during terminal phase (Vz) derived from plasma concentration		Up to 2 days
Secondary	Metabolite ratio determined using AUC(INF) for metabolite/AUC(INF) for BMS-986231 [MRAUC(INF)] derived from plasma concentration		Up to 2 days

External Links

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