NCT03515980

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2018

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 4, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

May 25, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2019

Completed
Last Updated

August 27, 2020

Status Verified

August 1, 2020

Enrollment Period

1.3 years

First QC Date

April 24, 2018

Last Update Submit

August 26, 2020

Conditions

Liver DysfunctionLiver InsufficiencyHepatic FailureMyocardial FailureCardiac FailureCongestive Heart FailureHeart Decompensation

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (4)

Mild hepatic impairment

EXPERIMENTAL

Based on Hepatic Function Impairment - Child-Pugh A score 5 to 6 points

Drug: BMS-986231

Moderate hepatic impairment

EXPERIMENTAL

Based on Hepatic Function Impairment - Child-Pugh B score 7 to 9 points

Drug: BMS-986231

Severe hepatic impairment

EXPERIMENTAL

Based on Hepatic Function Impairment - Child-Pugh C score 10 to 15 points

Drug: BMS-986231

Normal hepatic function

EXPERIMENTAL

Based on Hepatic Function Impairment as defined by the investigator

Drug: BMS-986231

Interventions

BMS-986231DRUG

Intravenous (IV) administration

Mild hepatic impairmentModerate hepatic impairmentNormal hepatic functionSevere hepatic impairment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Semmelweis Egyetem Altalanos Orvostudomanyi Kar

Budapest, 1083, Hungary

Location

Clinical Research Unit Hungary

Miskolc, 3529, Hungary

Location

BioVirtus Centrum Medyczne

Józefów, 05-410, Poland

Location

KO-MED Centra Kliniczne Lublin

Lublin, 20-954, Poland

Location

Related Links

MeSH Terms

Conditions

Liver DiseasesHepatic InsufficiencyLiver FailureHeart Failure

Condition Hierarchy (Ancestors)

Digestive System DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2018

First Posted

May 4, 2018

Study Start

May 25, 2018

Primary Completion

August 29, 2019

Study Completion

August 29, 2019

Last Updated

August 27, 2020

Record last verified: 2020-08

Locations

PL(2)HU(2)