Study in Healthy Adults Evaluating PF-07202954

Pfizer

Status and phase: Completed; Phase 1

Conditions: Liver Fibrosis; Non-Alcoholic Fatty Liver Disease

Treatments: Drug: Placebo; Drug: PF-07202954 Repeat Dose; Drug: PF-07202954 Single Dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT04857437

C4171001

2020-002121-28 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:- healthy subjects (all 3 Parts)

• evidence of steatosis on FibroScan (Part 2 only)
• BMI 17.5 to 30.5 kg/m2 (Part 1, Part 3)
• BMI 17.5 to 35.4 kg/m2 (Part 2) Exclusion Criteria:- evidence of clinically significant disease
• subjects on chronic medications
• clinically significant, abnormal laboratory results, vital signs, or cardiac conduction abnormalities
• contraindication to MRI (Part 2, only)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

Part 1

Experimental group

Description:

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

Treatment:

Drug: PF-07202954 Single Dose

Drug: Placebo

Part 2

Experimental group

Description:

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)

Treatment:

Drug: PF-07202954 Repeat Dose

Drug: Placebo

Part 3

Experimental group

Description:

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

Treatment:

Drug: PF-07202954 Single Dose