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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Nonalcoholic Fatty Liver Disease; NAFLD; Nonalcoholic Steatohepatitis

Treatments: Drug: BMS-986036

Study type: Interventional

Funder types: Industry

Identifiers

NCT03674476

2018-001497-19 (EudraCT Number)

MB130-065

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Mild Renal Impairment

Experimental group

Description:

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

Treatment:

Drug: BMS-986036

Moderate Renal Impairment

Experimental group

Description:

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

Treatment:

Drug: BMS-986036

Severe Renal Impairment

Experimental group

Description:

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

Treatment:

Drug: BMS-986036

Normal

Other group

Description:

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

Treatment:

Drug: BMS-986036