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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT03515980

Collaborator

(none)

Enrollment

Locations

Arms

15.1

Actual Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Liver Dysfunction Liver Insufficiency Hepatic Failure Myocardial Failure Cardiac Failure Congestive Heart Failure Heart Decompensation	Drug: BMS-986231	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

76 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 25, 2018

Actual Primary Completion Date :

Aug 29, 2019

Actual Study Completion Date :

Aug 29, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mild hepatic impairment Based on Hepatic Function Impairment - Child-Pugh A score 5 to 6 points	Drug: BMS-986231 Intravenous (IV) administration
Experimental: Moderate hepatic impairment Based on Hepatic Function Impairment - Child-Pugh B score 7 to 9 points	Drug: BMS-986231 Intravenous (IV) administration
Experimental: Severe hepatic impairment Based on Hepatic Function Impairment - Child-Pugh C score 10 to 15 points	Drug: BMS-986231 Intravenous (IV) administration
Experimental: Normal hepatic function Based on Hepatic Function Impairment as defined by the investigator	Drug: BMS-986231 Intravenous (IV) administration

Outcome Measures

Primary Outcome Measures

Area under the concentration-time curve from time 0 extrapolated to infinity [AUC(INF)] derived from plasma concentration [Up to 2 days]
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]
Maximum plasma concentration (Cmax) [Up to 2 days]

Secondary Outcome Measures

Incidence of adverse events (AE) [Up to 33 days]
Incidence of serious adverse events (SAE) [Up to 33 days]
Incidence of Laboratory Test Result Abnormalities [Up to 11 days]
Clearance (CL) derived from plasma concentration [Up to 2 days]
Terminal elimination half-life (t1/2) derived from plasma concentration [Up to 2 days]
Time of maximum observed plasma concentration (Tmax) [Up to 2 days]
Terminal elimination phase rate constant (λz) derived from plasma concentration [Up to 2 days]
Volume of distribution during terminal phase (Vz) derived from plasma concentration [Up to 2 days]
Metabolite ratio determined using AUC(INF) for metabolite/AUC(INF) for BMS-986231 [MRAUC(INF)] derived from plasma concentration [Up to 2 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Semmelweis Egyetem Altalanos Orvostudomanyi Kar	Budapest	Hungary	1083
2	Clinical Research Unit Hungary	Miskolc	Hungary	3529
3	BioVirtus Centrum Medyczne	Jozefow	Poland	05-410
4	KO-MED Centra Kliniczne Lublin	Lublin	Poland	20-954

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT03515980

Other Study ID Numbers:

CV013-026
2017-004914-24

First Posted:

May 4, 2018

Last Update Posted:

Aug 27, 2020

Last Verified:

Aug 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Liver Diseases

Liver Failure

Hepatic Insufficiency

Heart Failure

Study Results

No Results Posted as of Aug 27, 2020