Clinical trial NCT03513588: 2-Week Study In People With Nonalcoholic Fatty Liver Disease
Official title: A PHASE 1B, RANDOMIZED, DOUBLE-BLIND (SPONSOR-OPEN), PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACODYNAMICS AND PHARMACOKINETICS OF MULTIPLE ORAL DOSES OF PF- 06865571 FOR 2 WEEKS IN ADULTS WITH NONALCOHOLIC FATTY LIVER DISEASE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-alcoholic Steatohepatitis
Non-alcoholic Fatty Liver Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-05-01
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Exclusion Criteria:

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

Primary outcomes:
measure: Relative Change From Baseline in Whole Liver Fat at Day 15 as Assessed by Magnetic Resonance Imaging (MRI) - Proton Density Fat Fraction (PDFF)
timeFrame: Baseline (Day 1), Day 15
Secondary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days)
measure: Number of Participants With Laboratory Test Abnormalities
timeFrame: From first dose of study treatment up to 7-10 days after last dose (maximum of up to 24 days)
measure: Number of Participants With Vital Sign Abnormalities
timeFrame: From first dose of study treatment up to 7-10 days after last dose (maximum of up to 24 days)
measure: Number of Participants With Electrocardiogram (ECG) Abnormalities
timeFrame: From first dose of study treatment up to 7-10 days after last dose (maximum of up to 24 days)
measure: Maximum Plasma Concentration (Cmax) For PF-06865571
timeFrame: Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose
measure: Area Under the Plasma Concentration-Time Profile Over the Dosing Interval (AUCtau) For PF-06865571
timeFrame: Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose
measure: Time to Reach Maximum Plasma Concentration (Tmax) For PF-06865571
timeFrame: Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose
measure: Minimum Plasma Concentration (Cmin) For PF-06865571
timeFrame: Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose
measure: Apparent Oral Clearance (CL/F) For PF-06865571
timeFrame: Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose
measure: Peak-to-Trough Ratio (PTR) For PF-06865571
timeFrame: Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: New Haven
country: United States
facility: New Haven Clinical Research Unit
state: Connecticut
city: South Miami
country: United States
facility: Qps-Mra, Llc
state: Florida
city: Las Vegas
country: United States
facility: PPD Development, LP
state: Nevada
city: High Point
country: United States
facility: High Point Clinical Trials Center
state: North Carolina
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: