NCT03634969

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

3 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

Study Start

First participant enrolled

August 14, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 15, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

9 months

First QC Date

August 15, 2018

Last Update Submit

February 24, 2020

Conditions

Cardiac FailureMyocardial Failure

Outcome Measures

Primary Outcomes (12)

  • Maximum observed plasma concentration (Cmax) of BMS-986224

    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

    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

    Up to 11 days

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

    Up to 11 days

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

    Up to 11 days

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

    Up to 11 days

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

    Up to 11 days

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

    Up to 11 days

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

    Up to 11 days

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

    Part 1 only

    7 days

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

    Part 1 only

    7 days

  • Renal clearance of BMS-986224 derived from urine concentration

    Part 1 only

    7 days

Secondary Outcomes (12)

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

    Up to 41 days

  • Maximum observed plasma concentration (Cmax) of metabolite

    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

    Up to 11 days

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

    Up to 11 days

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

    Up to 11 days

  • +7 more secondary outcomes

Study Arms (5)

Normal Renal Function

EXPERIMENTAL
Drug: BMS-986224

Mild Renal Impairment

EXPERIMENTAL
Drug: BMS-986224

Moderate Renal Impairment

EXPERIMENTAL
Drug: BMS-986224

Severe Renal Impairment

EXPERIMENTAL
Drug: BMS-986224

End-Stage Renal Disease (ESRD)

EXPERIMENTAL

ESRD participants and are on chronic hemodialysis

Drug: BMS-986224

Interventions

BMS-986224DRUG

Specified dose on specified days

End-Stage Renal Disease (ESRD)Mild Renal ImpairmentModerate Renal ImpairmentNormal Renal FunctionSevere Renal Impairment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI ≥18 and ≤ 35kg/m2
  • Systolic blood pressure \>100 mmHg

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Clinical Pharmacology of Miami

Miami, Florida, 33014, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Prism Research

Saint Paul, Minnesota, 55114, United States

Location

Related Links

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart 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

August 15, 2018

First Posted

August 17, 2018

Study Start

August 14, 2018

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

February 25, 2020

Record last verified: 2020-02

Locations

US(3)