CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 48 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Placebo 0 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03513588
NCT03513588Phase 1Completed

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

Pfizer·interventional·Posted May 1, 2018·Updated Mar 13, 2020

In Brief

A Phase 1 clinical trial evaluating Placebo and PF-06865571 for Non-alcoholic Steatohepatitis and Non-alcoholic Fatty Liver Disease. Completed, enrolled 48 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedMay 1, 2018
Enrollment StartJun 21, 2018
Primary CompletionMar 8, 2019
Study CompletionApr 4, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 8.2 years ago

Interventions

Placebodrug

tablet, 0 mg, 14 days, every 12 hours

PF-06865571drug

tablet, 50 mg, 14 days, every 12 hours

PF-06865571drug

tablet, 300 mg, 14 days, every 12 hours