Study in Healthy Adults Evaluating PF-07202954

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-13

Study Completion Date

2021-09-17

Brief Summary

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The study is planned as a 3 part design with investigator and participant blinded (sponsor-open), placebo controlled, randomized, dose escalation in Part 1 and Part 2; and a randomized, open label design, in Part 3 (if conducted).

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Detailed Description

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Conditions

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Non-Alcoholic Fatty Liver Disease Liver Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Part 1

Single, Escalating Doses of PF-07202954 or Placebo (Cohorts 1 and 2)

Group Type EXPERIMENTAL

PF-07202954 Single Dose

Intervention Type DRUG

10, 30, 100, 300, 600, 900, 1200 milligrams (mg)

Placebo

Intervention Type DRUG

Matching Placebo

Part 2

Repeated, Escalating Doses of PF-07202954 or placebo from Day 1 to Day 14, inclusive (Cohorts 3, 4, 5, 6 7, and optional Cohort 8)

Group Type EXPERIMENTAL

PF-07202954 Repeat Dose

Intervention Type DRUG

10, 30, 100, 300, 600, 1200 milligrams (mg)

Placebo

Intervention Type DRUG

Matching Placebo

Part 3

Single dose of PF-07202954 with a high-fat/high-caloric meal and a single dose following an overnight fast of ≥10 hours

Group Type EXPERIMENTAL

PF-07202954 Single Dose

Intervention Type DRUG

10, 30, 100, 300, 600, 900, 1200 milligrams (mg)

Interventions

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PF-07202954 Repeat Dose

10, 30, 100, 300, 600, 1200 milligrams (mg)

Intervention Type DRUG

PF-07202954 Single Dose

10, 30, 100, 300, 600, 900, 1200 milligrams (mg)

Intervention Type DRUG

Placebo

Matching Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* evidence of steatosis on FibroScan (Part 2 only)
* BMI 17.5 to 30.5 kg/m2 (Part 1, Part 3)

Exclusion Criteria

* subjects on chronic medications
* clinically significant, abnormal laboratory results, vital signs, or cardiac conduction abnormalities
* contraindication to MRI (Part 2, only)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes