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

Bristol-Myers Squibb40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

NAFLD Nonalcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis

Interventions

BMS-986036DRUG

Specified dose on specified days

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

Pharmaceutical Research Associates CZ, s.r.o

Prague, Czechia

PRA Magyarorszag Kft

Budapest, Hungary

Semmelweis Egyetem

Budapest, Hungary

Clinical Research Unit Hungary

Miskolc, Hungary

Outcomes

Primary Outcomes

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

Time frame: Up to 30 days

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

Time frame: 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

Time frame: 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

Time frame: Up to 30 days

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

Time frame: Up to 30 days

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

Time frame: Up to 30 days

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

Time frame: Up to 30 days

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

Time frame: Up to 30 days

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

Time frame: Up to 30 days

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

Time frame: Up to 30 days

Secondary Outcomes

Data from ClinicalTrials.gov

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