The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-963272 compared to placebo in participants with nonalcoholic fatty liver disease (NAFLD) and high probability of advanced fibrosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
9
Specified dose on specified days
Specified dose on specified days
Cullman Clinical Trials
Cullman, Alabama, United States
Local Institution
Chandler, Arizona, United States
Incidence of adverse events (AEs)
Time frame: Up to 166 days
Incidence of serious adverse events (SAEs)
Time frame: Up to 166 days
Incidence of clinically significant changes in vital signs: Blood pressure
Time frame: Up to 166 days
Incidence of clinically significant changes in vital signs: Heart rate
Time frame: Up to 166 days
Incidence of clinically significant changes in physical examination findings
Time frame: Up to 166 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
PR interval: The time from the onset of the P wave to the start of the QRS complex
Time frame: Up to 166 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval
QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
Time frame: Up to 166 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
QT interval: Measured from the beginning of the QRS complex to the end of the T wave
Time frame: Up to 166 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval
QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)
Time frame: Up to 166 days
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Arizona Liver Health - Tucson
Tucson, Arizona, United States
Local Institution
Boca Raton, Florida, United States
RecioMed Clinical Research Network
Boynton Beach, Florida, United States
Local Institution
Miami, Florida, United States
Advanced Pharma - Miami
Miami, Florida, United States
Floridian Clinical Research
Miami Lakes, Florida, United States
Local Institution
Port Orange, Florida, United States
Local Institution
Bastrop, Louisiana, United States
...and 9 more locations
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry test
Time frame: Up to 166 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time frame: Up to 166 days
Incidence of clinically significant changes in clinical laboratory results: Coagulation tests
Time frame: Up to 166 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time frame: Up to 46 days
Incidence of clinically significant changes in clinical laboratory results: Liver function tests
Time frame: Up to 166 days
Incidence of clinically significant changes in clinical laboratory results: Lipid panel tests
Time frame: Up to 166 days
Pharmacokinetic (PK) sampling: Maximum observed plasma concentration (Cmax)
Time frame: Day 1 and Day 84
Pharmacokinetic (PK) sampling: Time to maximum observed plasma concentration (Tmax)
Time frame: Day 1 and Day 84
Pharmacokinetic (PK) sampling: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Time frame: Day 1 and Day 84
Trough observed plasma concentration (Ctrough)
Time frame: Day 1, Day 15, Day 29, Day 57, and Day 84