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2-Week Study In People With Nonalcoholic Fatty Liver Disease

Last updated on November 20, 2019

FOR MORE INFORMATION
Study Location
Anaheim Clinical Trials, LLC
Anaheim, California, 92801 United States
Contact
1-800-718-1021
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

NCT03513588
Pfizer
Not yet recruiting
2-Week Study In People With Nonalcoholic Fatty Liver Disease

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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 Summary2-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 DescriptionNot 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 DateMarch 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 CommitteeNo
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/da....
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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

1-800-718-1021

BY EMAIL

Contact

[email protected]

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