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An Investigational Study to Evaluate Experimental Medication BMS-986036 in Participants With Different Levels of Kidney Function

NCT ID: NCT03674476

Last Updated: 2019-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-11

Study Completion Date

2019-06-24

Brief Summary

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This is an investigational study to evaluate the experimental medication BMS-986036 in participants with different levels of kidney function.

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Detailed Description

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Conditions

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NAFLD Nonalcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mild Renal Impairment

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

Group Type EXPERIMENTAL

BMS-986036

Intervention Type DRUG

Specified dose on specified days

Moderate Renal Impairment

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

Group Type EXPERIMENTAL

BMS-986036

Intervention Type DRUG

Specified dose on specified days

Severe Renal Impairment

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

Group Type EXPERIMENTAL

BMS-986036

Intervention Type DRUG

Specified dose on specified days

Normal

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

Group Type OTHER

BMS-986036

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986036

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* BMI ≥ 25 and ≤ 40 kg/m2

Exclusion Criteria

* 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
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Pharmaceutical Research Associates CZ, s.r.o

Prague, , Czechia

Site Status

PRA Magyarorszag Kft

Budapest, , Hungary

Site Status

Semmelweis Egyetem

Budapest, , Hungary

Site Status

Clinical Research Unit Hungary

Miskolc, , Hungary

Site Status

Countries

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Czechia Hungary

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsstudyconnect.com/s/US/English/USenHome

BMS Clinical Trial Patient Recruiting

https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html

Investigator Inquiry Form

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

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2018-001497-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MB130-065

Identifier Type: -

Identifier Source: org_study_id

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