NCT04237831

Brief Summary

A study to evaluate the drug effect, safety, and tolerability of BMS-986259 in participants with different levels of kidney function

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2020

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

First Submitted

Initial submission to the registry

January 19, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

February 26, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2021

Completed
Last Updated

September 24, 2021

Status Verified

September 1, 2021

Enrollment Period

1.4 years

First QC Date

January 19, 2020

Last Update Submit

September 20, 2021

Conditions

Renal Failure

Outcome Measures

Primary Outcomes (11)

  • Maximum plasma Concentration (Cmax) of BMS-986259 in Blood serum

    Day 1 and Day 8

  • Time to reach maximum concentration in plasma (Tmax) of BMS-986259 in blood serum

    Day 1 and Day 8

  • Area under the concentration- time curve over the dosing interval of BMS-986259 in blood serum - AUC(TAU)

    Day 1 and Day 8

  • Concentration of BMS-986259 in blood serum at 24 hours (C24)

    Day 1 and Day 8

  • Area under the concentration-time curve of BMS-986259 from time 0 (dosing) to the time of the last quantifiable - AUC(0-T)

    Day 8

  • Accumulation ratio in the maximum plasma concentration of BMS-986259 in blood serum -AR(Cmax)

    Day 8

  • Accumulation ratio of Area under the concentration-time curve in BMS-986259 over the dosing interval -AR (AUC [TAU])

    Day 8

  • Accumulation ratio concentration of BMS-986259 at 24 hours- AR(C24)

    Day 8

  • Terminal elimination half-life of BMS-986259 (T-HALF)

    Day 8

  • Apparent total clearance of BMS-986259 at steady-state (CLss/F)

    Day 8

  • Apparent volume of distribution of BMS-986259 at terminal phase at steady-state (Vss/F)

    Day 8

Secondary Outcomes (7)

  • Incidence of Non serious Adverse Events (AEs)

    Up to 4 months

  • Incidence of Serious Adverse Events (SAEs)

    Up to 4 months

  • Incidence of AEs leading to discontinuation

    Up to 4 months

  • Number of clinically significant changes in vital signs

    Up to 4 months

  • Number in clinically significant changes in Electrocardiogram (ECG)

    Up to 4 months

  • +2 more secondary outcomes

Study Arms (4)

Arm A: Normal Renal Function

EXPERIMENTAL
Drug: BMS-986259

Arm B: Mild Renal Impairment

EXPERIMENTAL
Drug: BMS-986259

Arm C: Moderate Renal Impairment

EXPERIMENTAL
Drug: BMS-986259

Arm D: Severe Renal Impairment

EXPERIMENTAL
Drug: BMS-986259

Interventions

BMS-986259DRUG

Specified Dose on Specified Days

Arm A: Normal Renal FunctionArm B: Mild Renal ImpairmentArm C: Moderate Renal ImpairmentArm D: Severe Renal Impairment

Eligibility Criteria

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

You may qualify if:

  • Participant must have renal impairment, as defined by eGFR at screening using the Chronic Kidney Disease Epidemiology (CKD-EPI) equation
  • No change in medications to control Chronic Kidney Disease (CKD) for at least 2 weeks prior to dosing, and if possible, during confinement in the clinical research unit (CRU), except those cleared by the investigator and Medical Monitor.
  • Participants with normal renal function at screening, based upon the opinion of the investigator's medical evaluation.
  • Medically well-controlled disorders (eg, stable chronic asthma, allergy) are permitted if the treatment for the disease does not interfere with the study.
  • Women and men must use highly effective methods of contraception for the duration of treatment

You may not qualify if:

  • History of any significant drug allergy or drug-related Serious Adverse Events (SAE) (such as anaphylaxis or hepatotoxicity)
  • Positive results for drugs abuse in urine/saliva
  • Participants undergoing any method of dialysis (eg, hemodialysis, peritoneal dialysis) within the last 3 months or with anticipated need for dialysis during the study
  • Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory assessments beyond what is consistent with the target population
  • Known previous exposure to BMS-986259

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 Clinical Research

Saint Paul, Minnesota, 55114, United States

Location

Related Links

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney 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
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2020

First Posted

January 23, 2020

Study Start

February 26, 2020

Primary Completion

July 16, 2021

Study Completion

July 16, 2021

Last Updated

September 24, 2021

Record last verified: 2021-09

Locations

US(3)