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2-Week Study In People With Nonalcoholic Fatty Liver Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03513588
Recruitment Status : Completed
First Posted : May 1, 2018
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Non-alcoholic Steatohepatitis Non-alcoholic Fatty Liver Disease Drug: Placebo Drug: PF-06865571 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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
Actual Study Start Date : June 21, 2018
Actual Primary Completion Date : March 8, 2019
Actual Study Completion Date : April 4, 2019


Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
tablet, 0 mg, 14 days, every 12 hours

Experimental: PF-06865571 100 mg Drug: PF-06865571
tablet, 50 mg, 14 days, every 12 hours

Experimental: PF-06865571 600 mg Drug: PF-06865571
tablet, 300 mg, 14 days, every 12 hours




Primary Outcome Measures :
  1. Relative change from baseline in whole liver fat [ Time Frame: Baseline, Day 15 ]

Secondary Outcome Measures :
  1. Number of Participants With Treatment Emergent Treatment-Related Adverse Events [ Time Frame: Baseline up to 35 days from last dose ]
  2. Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities [ Time Frame: Baseline up to 35 days after last dose ]
  3. Number of Participants With Clinically Significant Change From Baseline in Vital Signs [ Time Frame: Baseline up to 35 days after last dose ]
  4. Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms [ Time Frame: Baseline up to 35 days after last dose ]
  5. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Day 14 ]
  6. Area Under the Curve from Time Zero to end of dosing interval (AUCtau) [ Time Frame: Day 14 ]
  7. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Day 14 ]
  8. Minimum Observed Plasma Trough Concentration (Cmin) [ Time Frame: Day 14 ]
  9. Apparent Oral Clearance (CL/F) [ Time Frame: Day 14 ]
  10. Plasma peak to trough ratio [ Time Frame: Day 14 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03513588


Locations
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United States, California
Anaheim Clinical Trials, LLC
Anaheim, California, United States, 92801
United States, Connecticut
New Haven Clinical Research Unit
New Haven, Connecticut, United States, 06511
United States, Florida
Qps-Mra, Llc
South Miami, Florida, United States, 33143
United States, Nevada
PPD Development, LP
Las Vegas, Nevada, United States, 89113
United States, North Carolina
High Point Clinical Trials Center
High Point, North Carolina, United States, 27265
United States, Texas
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03513588     History of Changes
Other Study ID Numbers: C2541005
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases