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

Phase 1

Completed

• Conditions: NAFLD; Nonalcoholic Steatohepatitis; Nonalcoholic Fatty Liver Disease
• Interventions: Drug: BMS-986036

• Registration Number: NCT03674476
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-08-29
• Study Start: 2018-09-11
• Study First Submitted QC: 2018-09-14
• Study First Posted: 2018-09-17
• Primary Completion: 2019-06-24
• Study Completion: 2019-06-24
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-04
• Last Update Posted: 2019-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• BMI ≥ 25 and ≤ 40 kg/m2

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal	BMS-986036	The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening.
Mild Renal Impairment	BMS-986036	The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening.
Moderate Renal Impairment	BMS-986036	The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening.
Severe Renal Impairment	BMS-986036	The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening.

Primary Outcome Measures

Name	Time	Method
Maximum observed serum concentration (Cmax) 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
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
Total amount excreted into urine (Ae) of C-terminal intact BMS-986036	Up to 30 days

Secondary Outcome Measures

Name	Time	Method
Incidence of serious adverse events (SAE)	Up to 30 days
Apparent total body clearance (CLT/F) of total BMS-986036	Up to 30 days
Incidence of adverse events (AE)	Up to 30 days
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
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
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 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
Incidence of clinically significant changes to events of special interest	Up to 30 days	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

Trial Locations

Locations (4)

Pharmaceutical Research Associates CZ, s.r.o; 🇨🇿 Praha 7, Czechia

Clinical Research Unit Hungary; 🇭🇺 Miskolc, Hungary

PRA Magyarorszag Kft; 🇭🇺 Budapest, Hungary

Semmelweis Egyetem; 🇭🇺 Budapest, Hungary