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Study in Healthy Adults Evaluating PF-07202954

Primary Purpose

Non-Alcoholic Fatty Liver Disease, Liver Fibrosis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

PF-07202954 Repeat Dose

PF-07202954 Single Dose

Placebo

About this trial

This is an interventional basic science trial for Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

New Haven Clinical Research Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Part 1

Part 2

Part 3

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of Subjects reporting treatment emergent adverse events (AEs)

Part 1 and Part 2

Incidence of treatment emergent clinical laboratory abnormalities

Part 1 and Part 2

Incidence of treatment emergent vital signs

Part 1 and Part 2

Incidence of treatment emergent Electrocardiogram (ECG) abnormalities

Part 1 and Part 2

Maximum plasma concentration (C[max])

Part 3 (if conducted)

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Part 3 (if conducted)

Area under the plasma concentration time AUC[last])

Part 3 (if conducted)

Area Under the Curve from Time Zero to Extrapolated Infinite Time (AUCinf)

Part 3 (if conducted)

Secondary Outcome Measures

Cmax

Part 1 and Part 2

Tmax

Part 1 and Part 2

AUClast

Part 1

AUCinf

Part 1

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)

Part 2

Time measured for plasma concentration to decrease by one half (Terminal half-life) [t(1/2)].

Part 1 and Part 2

Amount of unchanged drug recovered in urine during dosing interval (AE[tau])

Part 2

Percent of dose recovered in urine as unchanged drug over dosing interval (AE[tau%])

Part 2

Renal Clearance (CLr)

Part 2

AEs

Part 3 (if conducted)

Incidence of treatment emergent clinical laboratory abnormalities

Part 3 (if conducted)

Incidence of treatment emergent vital signs

Part 3 (if conducted)

ECG abnormalities

Part 3 (if conducted)

Full Information

NCT ID

NCT04857437

First Posted

April 20, 2021

Last Updated

November 11, 2021

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT04857437

Brief Title

Study in Healthy Adults Evaluating PF-07202954

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

May 13, 2021 (Actual)

Primary Completion Date

September 17, 2021 (Actual)

Study Completion Date

September 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Alcoholic Fatty Liver Disease, Liver Fibrosis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part 1

Arm Type

Experimental

Arm Description

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

Arm Title

Part 2

Arm Type

Experimental

Arm 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)

Arm Title

Part 3

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

PF-07202954 Repeat Dose

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

PF-07202954 Single Dose

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching Placebo

Primary Outcome Measure Information:

Title

Number of Subjects reporting treatment emergent adverse events (AEs)

Description

Part 1 and Part 2

Time Frame

Baseline through follow up Day 30

Title

Incidence of treatment emergent clinical laboratory abnormalities

Description

Part 1 and Part 2

Time Frame

Baseline through follow up Day 30

Title

Incidence of treatment emergent vital signs

Description

Part 1 and Part 2

Time Frame

Baseline through follow up Day 30

Title

Incidence of treatment emergent Electrocardiogram (ECG) abnormalities

Description

Part 1 and Part 2

Time Frame

Baseline through follow up Day 30

Title

Maximum plasma concentration (C[max])

Description

Part 3 (if conducted)

Time Frame

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

Title

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Description

Part 3 (if conducted)

Time Frame

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

Title

Area under the plasma concentration time AUC[last])

Description

Part 3 (if conducted)

Time Frame

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

Title

Area Under the Curve from Time Zero to Extrapolated Infinite Time (AUCinf)

Description

Part 3 (if conducted)

Time Frame

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 Measure Information:

Title

Cmax

Description

Part 1 and Part 2

Time Frame

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

Title

Tmax

Description

Part 1 and Part 2

Time Frame

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

Title

AUClast

Description

Part 1

Time Frame

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.

Title

AUCinf

Description

Part 1

Time Frame

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.

Title

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)

Description

Part 2

Time Frame

Part 2 (Single Dose) - Day 1. Part 2 (Repeat Dose) - Day 7 and Day 14

Title

Time measured for plasma concentration to decrease by one half (Terminal half-life) [t(1/2)].

Description

Part 1 and Part 2

Time Frame

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

Title

Amount of unchanged drug recovered in urine during dosing interval (AE[tau])

Description

Part 2

Time Frame

Day 14

Title

Percent of dose recovered in urine as unchanged drug over dosing interval (AE[tau%])

Description

Part 2

Time Frame

Day 14

Title

Renal Clearance (CLr)

Description

Part 2

Time Frame

Day 14

Title

AEs

Description

Part 3 (if conducted)

Time Frame

Baseline through follow up Day 30

Title

Incidence of treatment emergent clinical laboratory abnormalities

Description

Part 3 (if conducted)

Time Frame

Baseline through follow up Day 30

Title

Incidence of treatment emergent vital signs

Description

Part 3 (if conducted)

Time Frame

Baseline through follow up Day 30

Title

ECG abnormalities

Description

Part 3 (if conducted)

Time Frame

Baseline through follow up Day 30

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

New Haven Clinical Research Unit

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06511

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing 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.

Links:

URL

https://pmiform.com/clinical-trial-info-request?StudyID=C4171001

Description

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

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Study in Healthy Adults Evaluating PF-07202954

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