NCT03674476

Brief Summary

This is an investigational study to evaluate the experimental medication BMS-986036 in participants 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
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 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

August 29, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

September 11, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2019

Completed
Last Updated

October 8, 2019

Status Verified

October 1, 2019

Enrollment Period

10 months

First QC Date

August 29, 2018

Last Update Submit

October 4, 2019

Conditions

NAFLDNonalcoholic Fatty Liver DiseaseNonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (10)

  • Maximum observed serum concentration (Cmax) of C-terminal intact BMS-986036

    Up to 30 days

  • Time of maximum observed serum concentration (Tmax) of C-terminal intact BMS-986036

    Up to 30 days

  • Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of C-terminal intact BMS-986036

    Up to 30 days

  • Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of C-terminal intact BMS-986036

    Up to 30 days

  • Terminal elimination half-life (T-half) of C-terminal intact BMS-986036

    Up to 30 days

  • Apparent total body clearance (CLT/F) of C-terminal intact BMS-986036

    Up to 30 days

  • Apparent volume of distribution (Vz/F) of C-terminal intact BMS-986036

    Up to 30 days

  • Total renal clearance (CLR) of C-terminal intact BMS-986036

    Up to 30 days

  • Amount per fraction excreted into urine (Fe) of C-terminal intact BMS-986036

    Up to 30 days

  • Total amount excreted into urine (Ae) of C-terminal intact BMS-986036

    Up to 30 days

Secondary Outcomes (14)

  • Maximum observed serum concentration (Cmax) of total BMS-986036

    Up to 30 days

  • Time of maximum observed serum concentration (Tmax) of total BMS-986036

    Up to 30 days

  • Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of total BMS-986036

    Up to 30 days

  • Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of total BMS-986036

    Up to 30 days

  • Terminal elimination half-life (T-half) of total BMS-986036

    Up to 30 days

  • +9 more secondary outcomes

Study Arms (4)

Mild Renal Impairment

EXPERIMENTAL

The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening.

Drug: BMS-986036

Moderate Renal Impairment

EXPERIMENTAL

The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening.

Drug: BMS-986036

Severe Renal Impairment

EXPERIMENTAL

The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening.

Drug: BMS-986036

Normal

OTHER

The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening.

Drug: BMS-986036

Interventions

BMS-986036DRUG

Specified dose on specified days

Mild Renal ImpairmentModerate Renal ImpairmentNormalSevere Renal Impairment

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI ≥ 25 and ≤ 40 kg/m2

You may not qualify if:

  • Presence of any factors that would predispose the participant to infection (eg, extensive periodontal disease that warrants surgical or medical treatment, unhealed open wounds)
  • Any bone trauma (fracture) or bone surgery (ie, hardware placement, joint replacement, bone grafting, or amputation) within 3 months of study drug administration
  • Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
  • Any major surgery (eg, abdominal, thoracal, or cranial procedures) within 6 weeks of study drug administration
  • Donation of blood or plasma to a blood bank, or in a clinical study (except at the screening visit) within 6 weeks of study drug administration
  • Inability to tolerate subcutaneous injections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Pharmaceutical Research Associates CZ, s.r.o

Prague, 170 00, Czechia

Location

PRA Magyarorszag Kft

Budapest, 1077, Hungary

Location

Semmelweis Egyetem

Budapest, 1083, Hungary

Location

Clinical Research Unit Hungary

Miskolc, 3529, Hungary

Location

Related Links

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Pegbelfermin

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System 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 29, 2018

First Posted

September 17, 2018

Study Start

September 11, 2018

Primary Completion

June 24, 2019

Study Completion

June 24, 2019

Last Updated

October 8, 2019

Record last verified: 2019-10

Locations

HU(3)CZ(1)