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2-Week Study In People With Nonalcoholic Fatty Liver Disease

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NCT03513588

Last updated on August 21, 2018
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FOR MORE INFORMATION
Study Location
New Haven Clinical Research Unit
New Haven, Connecticut, 06511 United States
See other locations
Contact
1-800-254-6398
[email protected]
Related Links
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
Recruiting
2-Week Study In People With Nonalcoholic Fatty Liver Disease

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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2-Week Study In People With Nonalcoholic Fatty Liver Disease
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
  • Non-alcoholic Steatohepatitis
  • Non-alcoholic Fatty Liver Disease
  • 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
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: PF-06865571 100 mg
    Intervention: Drug: PF-06865571
  • Experimental: PF-06865571 600 mg
    Intervention: Drug: PF-06865571
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
45
Same as current
February 20, 2019
February 20, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Not Provided
 
 
NCT03513588
C2541005
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2018

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 thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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