Study in Healthy Adults Evaluating PF-07202954

A PHASE 1, 3-PART, SPONSOR OPEN STUDY OF PF-07202954 IN HEALTHY ADULTS: RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TO ASSESS SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE (IN PART 1), AND REPEATED (IN PART 2), ESCALATING, ORAL DOSES ALONG WITH CONDITIONAL PART 3 OF RANDOMIZED, OPEN-LABEL ASSESSMENT OF EFFECT OF FOOD ON PF-07202954 EXPOSURE

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).

Study Overview

• Status: Completed
• Conditions: Liver Fibrosis; Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Drug: Placebo; Drug: PF-07202954 Single Dose; Drug: PF-07202954 Repeat Dose

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • New Haven Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Part 1; Single, Escalating Doses of PF-07202954 or Placebo (Cohorts 1 and 2)	Drug: Placebo; Matching Placebo; Drug: PF-07202954 Single Dose; 10, 30, 100, 300, 600, 900, 1200 milligrams (mg)
EXPERIMENTAL: 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)	Drug: Placebo; Matching Placebo; Drug: PF-07202954 Repeat Dose; 10, 30, 100, 300, 600, 1200 milligrams (mg)
EXPERIMENTAL: 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	Drug: PF-07202954 Single Dose; 10, 30, 100, 300, 600, 900, 1200 milligrams (mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects reporting treatment emergent adverse events (AEs)	Part 1 and Part 2	Baseline through follow up Day 30
Incidence of treatment emergent clinical laboratory abnormalities	Part 1 and Part 2	Baseline through follow up Day 30
Incidence of treatment emergent vital signs	Part 1 and Part 2	Baseline through follow up Day 30
Incidence of treatment emergent Electrocardiogram (ECG) abnormalities	Part 1 and Part 2	Baseline through follow up Day 30
Maximum plasma concentration (C[max])	Part 3 (if conducted)	0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16 hour on Day 1, 24, 36 hour on Day 2, 48 hour on Day 3, 72 hour on Day 4
Time to Reach Maximum Observed Plasma Concentration (Tmax)	Part 3 (if conducted)	0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16 hour on Day 1, 24, 36 hour on Day 2, 48 hour on Day 3, 72 hour on Day 4
Area under the plasma concentration time AUC[last])	Part 3 (if conducted)	0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16 hour on Day 1, 24, 36 hour on Day 2, 48 hour on Day 3, 72 hour on Day 4
Area Under the Curve from Time Zero to Extrapolated Infinite Time (AUCinf)	Part 3 (if conducted)	0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16 hour on Day 1, 24, 36 hour on Day 2, 48 hour on Day 3, 72 hour on Day 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Part 1 and Part 2	Part 1 - 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16 hour on Day 1, 24, 36 hour on Day 2, 48 hour on Day 3, 72 hour on Day 4. Part 2 (Single Dose) - Day 1. Part 2 (Repeat Dose) - Day 7 and Day 14
Tmax	Part 1 and Part 2	Part 1 - 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16 hour on Day 1, 24, 36 hour on Day 2, 48 hour on Day 3, 72 hour on Day 4. Part 2 (Single Dose) - Day 1. Part 2 (Repeat Dose) - Day 7 and Day 14
AUClast	Part 1	Part 1 - 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16 hour on Day 1, 24, 36 hour on Day 2, 48 hour on Day 3, 72 hour on Day 4.
AUCinf	Part 1	Part 1 - 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16 hour on Day 1, 24, 36 hour on Day 2, 48 hour on Day 3, 72 hour on Day 4.
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)	Part 2	Part 2 (Single Dose) - Day 1. Part 2 (Repeat Dose) - Day 7 and Day 14
Time measured for plasma concentration to decrease by one half (Terminal half-life) [t(1/2)].	Part 1 and Part 2	Part 1 - 0, 0.5, 1, 2, 3, 4, 5, 8, 12, 16 hour on Day 1, 24, 36 hour on Day 2, 48 hour on Day 3, 72 hour on Day 4. Part 2 (Repeat Dose) - Day 14
Amount of unchanged drug recovered in urine during dosing interval (AE[tau])	Part 2	Day 14
Percent of dose recovered in urine as unchanged drug over dosing interval (AE[tau%])	Part 2	Day 14
Renal Clearance (CLr)	Part 2	Day 14
AEs	Part 3 (if conducted)	Baseline through follow up Day 30
Incidence of treatment emergent clinical laboratory abnormalities	Part 3 (if conducted)	Baseline through follow up Day 30
Incidence of treatment emergent vital signs	Part 3 (if conducted)	Baseline through follow up Day 30
ECG abnormalities	Part 3 (if conducted)	Baseline through follow up Day 30

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 13, 2021
• Primary Completion (ACTUAL): September 17, 2021
• Study Completion (ACTUAL): September 17, 2021

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (ACTUAL): April 23, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 15, 2021
• Last Update Submitted That Met QC Criteria: November 11, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Fibrosis; Liver Diseases; Fatty Liver; Liver Cirrhosis; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: C4171001; 2020-002121-28 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No