NCT03332186

Brief Summary

The purpose of this study is to investigate experimental medication BMS-986231 in patients with different levels of kidney function.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2018

Shorter than P25 for phase_1

Geographic Reach
2 countries

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

First Submitted

Initial submission to the registry

November 2, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

March 15, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2018

Completed
Last Updated

September 11, 2019

Status Verified

September 1, 2019

Enrollment Period

7 months

First QC Date

November 2, 2017

Last Update Submit

September 10, 2019

Conditions

Myocardial FailureCardiac FailureCongestive Heart FailureKidney FailureRenal Failure

Outcome Measures

Primary Outcomes (5)

  • Maximum observed plasma concentration (Cmax) derived from plasma concentration

    11 days

  • Area under the concentration-time curve from time 0 extrapolated to infinity [AUC(0-inf)] derived from plasma concentration

    11 days

  • Metabolite ratio determined using AUC0-inf for metabolite/AUC0-inf [MRAUC(0-inf)] derived from plasma concentration

    11 days

  • Clearance (CL) derived from plasma concentration

    11 days

  • Renal clearance (CLR) derived from urine concentration

    11 days

Secondary Outcomes (9)

  • Number of adverse events (AE)

    Up to 31 days

  • Number of serious adverse events (SAE)

    Up to 31 days

  • Terminal elimination half-life (t1/2)

    Up to 36 hours

  • Time of maximum observed plasma concentration (Tmax)

    Up to 36 hours

  • AUC up to time t, where t is the last time point with concentrations above the lower limit of quantitation (AUCt)

    Up to 36 hours

  • +4 more secondary outcomes

Study Arms (4)

Mild Renal Impairment

EXPERIMENTAL

Mild renal impairment defined as eGFR 60 to \<90 mL/min/1.73 m\^2

Drug: BMS-986231

Moderate renal impairment

EXPERIMENTAL

Moderate renal impairment defined as eGFR 30 to \<60 mL/min/1.73 m\^2

Drug: BMS-986231

Severe renal impairment

EXPERIMENTAL

Severe renal impairment defined as eGFR \<30 mL/min/1.73 m\^2, not requiring dialysis

Drug: BMS-986231

Normal renal function

EXPERIMENTAL

Normal renal function defined as eGFR ≥90 mL/min/1.73 m\^2

Drug: BMS-986231

Interventions

BMS-986231DRUG

Intravenous infusion administration

Mild Renal ImpairmentModerate renal impairmentNormal renal functionSevere renal 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
  • BMI ≥ 18 kg/m\^2 and ≤ 35 kg/m\^2
  • Heart rate ≥ 50 bpm and \< 95 bpm
  • Stable renal impairment, defined as no clinically significant change in disease status, as documented by the subject's most recent eGFR assessment
  • No changes in medication within 30 days prior to study drug administration

You may not qualify if:

  • Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests
  • History of chronic headaches, defined as occurring 15 days or more a month, over the previous 3 months
  • History of headaches related to caffeine withdrawal
  • History of migraine or cluster headaches
  • Patients requiring dialysis will not be enrolled in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Local Institution

Prague, 170 00, Czechia

Location

Samodzielny Publiczny Secjalistyczny Szpital Zachodni im. sw. Jana Pawla II

Grodzisk Mazowiecki, 05-825, Poland

Location

Specjalistyczne Centrum Medyczne Panacea Poznan

Krakow, 31-559, Poland

Location

Related Links

MeSH Terms

Conditions

Heart FailureRenal Insufficiency

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital 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

November 2, 2017

First Posted

November 6, 2017

Study Start

March 15, 2018

Primary Completion

October 22, 2018

Study Completion

October 22, 2018

Last Updated

September 11, 2019

Record last verified: 2019-09

Locations

CZ(1)PL(2)