2-Week Study In People With Nonalcoholic Fatty Liver Disease

Phase 1

Completed

• Conditions: Non-alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis
• Interventions: Drug: PF-06865571; Drug: Placebo

• Registration Number: NCT03513588
• Lead Sponsor: Pfizer

Brief Summary

2-week study in people with nonalcoholic fatty liver disease. Study drug at 1 of 2 doses, or placebo, will be given for 14 days. Blood samples, heart monitoring, vital signs, and imaging procedures will be performed.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-19
• Study First Submitted QC: 2018-04-19
• Study First Posted: 2018-05-01
• Study Start: 2018-06-21
• Primary Completion: 2019-03-08
• Study Completion: 2019-04-04
• Status Verified: 2020-02
• Results First Submitted: 2020-02-28
• Results First Submitted QC: 2020-02-28
• Last Update Submitted: 2020-02-28
• Results First Posted: 2020-03-13
• Last Update Posted: 2020-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• controlled attenuation parameter greater than or equal to 260 dB/m via FibroScan
• liver fat greater than or equal to 6% via MRI

Read More

Exclusion Criteria

• Chronic liver disease
• Type 2 diabetes requiring drug treatment
• Unable to undergo MRI
• History of heart attack or stroke

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PF-06865571 100 mg	PF-06865571	-
PF-06865571 600 mg	PF-06865571	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Relative Change From Baseline in Whole Liver Fat at Day 15 as Assessed by Magnetic Resonance Imaging (MRI) - Proton Density Fat Fraction (PDFF)	Baseline (Day 1), Day 15	MRI-PDFF is an established method that enables quantification of fat content in the liver. The value of whole liver fat as assessed by MRI-PDFF is expressed in percentage and ranges from 0 to 100% with higher values representing higher liver fat level.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Vital Sign Abnormalities	From first dose of study treatment up to 7-10 days after last dose (maximum of up to 24 days)	Vital sign categorical summarization criteria: 1) supine systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) \<50 mmHg; 3) pulse rate \<40 or \>120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine DBP greater than or equal to (\>=) 20 mmHg; 5) change from baseline (increase or decrease) in supine SBP \>=30 mmHg.
Area Under the Plasma Concentration-Time Profile Over the Dosing Interval (AUCtau) For PF-06865571	Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose	AUCtau of PF-06865571 on Day 14 was obtained by linear/log trapezoidal method. The dosing interval (tau) was 12 hours. Geometric coefficients of variations were reported as percentages.
Apparent Oral Clearance (CL/F) For PF-06865571	Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose	CL/F of PF-06865571 on Day 14 was calculated as Dose/AUCtau. Geometric coefficients of variations were reported as percentages.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days)	An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity on or after the first dose of investigational product administration. AEs included both SAEs and non-serious AEs.
Minimum Plasma Concentration (Cmin) For PF-06865571	Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose	Cmin of PF-06865571 on Day 14 was observed directly from data. Geometric coefficients of variations were reported as percentages.
Maximum Plasma Concentration (Cmax) For PF-06865571	Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose	Cmax of PF-06865571 on Day 14 was observed directly from data. Geometric coefficients of variations were reported as percentages.
Number of Participants With Laboratory Test Abnormalities	From first dose of study treatment up to 7-10 days after last dose (maximum of up to 24 days)	Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes); chemistry (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, protein, albumin, urea nitrogen, creatinine, urate, sodium, potassium, calcium, chloride, bicarbonate); urinalysis (urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, urine erythrocytes, urine leukocytes, hyaline casts); biomarker (total cholesterol, low-density and high-density lipoprotein cholesterol, triglycerides, fasting glucose). Participants with any of the laboratory test abnormalities were counted.
Number of Participants With Electrocardiogram (ECG) Abnormalities	From first dose of study treatment up to 7-10 days after last dose (maximum of up to 24 days)	ECG categorical summarization criteria: 1) QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): \>=140 milliseconds (msec), \>=50% change from baseline; 2) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): \>=300 msec, \>=25% change when baseline is \> 200 msec or \>=50% change when baseline is less than or equal to (\<=) 200 msec; 3) QTcF interval (heart rate corrected QT \[time between the start of the ECG Q wave and the end of the T wave in the heart's electrical cycle\] using Fridericia's formula): absolute value of \>450 to 480 msec, \>480 to 500 msec, \>500 msec; a change from baseline of \>30 to 60 msec or \>60 msec.
Time to Reach Maximum Plasma Concentration (Tmax) For PF-06865571	Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose	Tmax of PF-06865571 on Day 14 was observed directly from data as time of Cmax occurrence.
Peak-to-Trough Ratio (PTR) For PF-06865571	Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose	PTR of PF-06865571 on Day 14 was calculated as Cmax/Cmin. Geometric coefficients of variations were reported as percentages.

Trial Locations

Locations (6)

Anaheim Clinical Trials, LLC; 🇺🇸 Anaheim, California, United States

Qps-Mra, Llc; 🇺🇸 South Miami, Florida, United States

High Point Clinical Trials Center; 🇺🇸 High Point, North Carolina, United States

New Haven Clinical Research Unit; 🇺🇸 New Haven, Connecticut, United States

PPD Development, LP; 🇺🇸 Las Vegas, Nevada, United States

Clinical Trials of Texas, Inc.; 🇺🇸 San Antonio, Texas, United States