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

A Phase 1, Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986036 in Participants With Varying Degrees of Renal Function

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

Study Overview

• Status: Completed
• Conditions: NAFLD; Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis
• Intervention / Treatment: Drug: BMS-986036

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Czechia
  • Praha 7, Czechia, 170 00
    • Pharmaceutical Research Associates CZ, s.r.o
• Hungary
  • Budapest, Hungary, 1083
    • Semmelweis Egyetem
  • Budapest, Hungary, 1077
    • PRA Magyarorszag Kft
  • Miskolc, Hungary, 3529
    • Clinical Research Unit Hungary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mild Renal Impairment; The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening.	Drug: BMS-986036; Specified dose on specified days
Experimental: Moderate Renal Impairment; The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening.	Drug: BMS-986036; Specified dose on specified days
Experimental: Severe Renal Impairment; The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening.	Drug: BMS-986036; Specified dose on specified days
Other: Normal; The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening.	Drug: BMS-986036; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Apparent total body clearance (CLT/F) of total BMS-986036		Up to 30 days
Apparent volume of distribution (Vz/F) of total BMS-986036		Up to 30 days
Total renal clearance (CLR) of total BMS-986036		Up to 30 days
Amount per fraction excreted into urine (Fe) of total BMS-986036		Up to 30 days
Total amount excreted into urine (Ae) of total BMS-986036		Up to 30 days
Incidence of injection site reactions (prospective)		Up to 30 days
Incidence of adverse events (AE)		Up to 30 days
Incidence of serious adverse events (SAE)		Up to 30 days
Incidence of clinically significant changes to events of special interest	Events of special interest include injection site assessment, AEs leading to discontinuation, and deaths as well as AEs related to marked abnormalities in clinical laboratory tests, vital sign measurements, electrocardiogram (ECGs), and physical examinations	Up to 30 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2018
• Primary Completion (Actual): June 24, 2019
• Study Completion (Actual): June 24, 2019

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: September 14, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): October 8, 2019
• Last Update Submitted That Met QC Criteria: October 4, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: MB130-065; 2018-001497-19 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes