2-Week Study In People With Nonalcoholic Fatty Liver Disease

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NCT03513588

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Study Location
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
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Contact
1-800-254-6398
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-254-6398

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-alcoholic Steatohepatitis, Non-alcoholic Fatty Liver Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Chronic liver disease


- Type 2 diabetes requiring drug treatment


- Unable to undergo MRI


- History of heart attack or stroke

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Pfizer Clinical Trials Contact Center

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[email protected]

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Non-alcoholic Steatohepatitis, Non-alcoholic Fatty Liver Disease2-Week Study In People With Nonalcoholic Fatty Liver Disease
NCT03513588
  1. Anaheim, California
  2. New Haven, Connecticut
  3. South Miami, Florida
  4. Las Vegas, Nevada
  5. High Point, North Carolina
  6. San Antonio, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE 2-Week Study In People With Nonalcoholic Fatty Liver Disease
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Non-alcoholic Steatohepatitis
  • Non-alcoholic Fatty Liver Disease
Intervention  ICMJE
  • Drug: Placebo
    tablet, 0 mg, 14 days, every 12 hours
  • Drug: PF-06865571
    tablet, 50 mg, 14 days, every 12 hours
  • Drug: PF-06865571
    tablet, 300 mg, 14 days, every 12 hours
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: PF-06865571 100 mg
    Intervention: Drug: PF-06865571
  • Experimental: PF-06865571 600 mg
    Intervention: Drug: PF-06865571
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 29, 2019)		48
Original Estimated Enrollment  ICMJE
 (submitted: April 19, 2018)		45
Actual Study Completion Date  ICMJE April 4, 2019
Actual Primary Completion Date March 8, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03513588
Other Study ID Numbers  ICMJE C2541005
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP