| 2-Week Study In People With Nonalcoholic Fatty Liver Disease
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| 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
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| 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.
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| Not Provided
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| Interventional
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| Phase 1
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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- Non-alcoholic Steatohepatitis
- Non-alcoholic Fatty Liver Disease
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- 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
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- Placebo Comparator: Placebo
Intervention: Drug: Placebo
- Experimental: PF-06865571 100 mg
Intervention: Drug: PF-06865571
- Experimental: PF-06865571 600 mg
Intervention: Drug: PF-06865571
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| Not Provided
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| |
| Completed
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| 48
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| 45
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| April 4, 2019
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| March 8, 2019 (Final data collection date for primary outcome measure)
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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
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| Sexes Eligible for Study: |
All |
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| 18 Years to 65 Years (Adult, Older Adult)
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| No
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Contact information is only displayed when the study is recruiting subjects
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| United States
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| NCT03513588
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| C2541005
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| No
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| Studies a U.S. FDA-regulated Drug Product: |
Yes |
| Studies a U.S. FDA-regulated Device Product: |
No |
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| 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.... |
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| Pfizer
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| Pfizer
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| Not Provided
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| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
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| Pfizer
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| June 2019
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