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A Study to Learn About How Loss of Liver Function Affects the Blood Levels of the Study Medicine Called PF-07817883.

Primary Purpose

COVID-19

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PF-07817883
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for COVID-19 focused on measuring Hepatic Impairment, COVID-19

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: (HI Cohorts Only): Stable HI that meets criteria for Class A or B of the Child-Pugh classification; (all Cohorts): BMI of 17.5 to 38.0 kg/m2 Exclusion Criteria: Any condition possibly affecting drug absorption Additional Exclusion Criteria for HI Cohorts Only Limited predicted life expectancy Hepatic dysfunction secondary to acute ongoing hepatocellular process. Signs of clinically active Grade 2, 3 or 4 hepatic encephalopathy. Severe ascites and/or pleural effusion History of kidney, liver, or heart transplantation. Persistent severe, uncontrolled hypertension.

Sites / Locations

  • Anaheim Clinical Trials, LLCRecruiting
  • National Institute of Clinical ResearchRecruiting
  • Catalina Research Institute, LLCRecruiting
  • Research Centers of America ( Hollywood )Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Arm Description

No hepatic impairment

Mild hepatic impairment

Moderate hepatic impairment

Severe hepatic impairment

Outcomes

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) of PF-07817883
Plasma PF-07817883 PK parameters
Area Under the Plasma Concentration-time Profile from Time Zero to Extrapolated Infinite Time (AUCinf)
Plasma PF-07817883 PK parameter
Area Under the Plasma Concentration-time Profile from Time Zero to the Time of the Last Quantifiable Concentration (AUClast)
(Optional) Plasma PF-07817883 parameter

Secondary Outcome Measures

Number of Participants with Non-Serious Adverse Events
Safety Parameters
Number of Participants with Treatment Emergent Adverse Events
Safety Parameters
Number of Participants with Clinically Significant ECG Abnormalities
ECG parameters include QTcF, QRS, RR interval, PR interval, and Heart Rate
Number of Participants with Clinically Significant Abnormal Vital Signs
Vital Signs parameters include diastolic blood pressure, systolic blood pressure, and pulse rate
Number of Participants with Clinically Significant Abnormal Laboratory Values
Blood hematology and Chemistry and Urinalysis
Number of Participants with Serious Adverse Events
Safety Parameters

Full Information

First Posted
May 23, 2023
Last Updated
August 1, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05884554
Brief Title
A Study to Learn About How Loss of Liver Function Affects the Blood Levels of the Study Medicine Called PF-07817883.
Official Title
A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO ASSESS PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-07817883 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
July 20, 2024 (Anticipated)
Study Completion Date
July 20, 2024 (Anticipated)

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
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to learn about the safety of PF-07817883 and how PF-07817883 is processed in the body of adult participants. These participants will have different degrees of loss of liver function. Participants with mild, moderate, severe or no loss of liver function will be enrolled in 4 groups. This study is seeking participants who: are male or female of 18- 75 years of age either have different amounts of damage to liver function or for one of the groups, no damage willing to follow the requirements of the study including stay at clinic for 6 nights and 7 days About, 6-8 participants will be selected in groups 1, 2 and 3. In group 4, around 4 to 8 participants will be selected. If participants consent to participate in the study, it may take up to 4 weeks to complete all the tests to confirm if they are eligible to participate in the study. If they seem to be eligible for the study, participants will be admitted to a clinic research unit (CRU) atleast 12 hours before dosing. On Day 1, participants will receive a single dose of study medicine (Day 1). A series of blood samples will be collected before and after dosing. Participants will be discharged from the CRU on Day 6. A follow-up phone call (on CRU visit, if needed), will occur 28-35 days after dosing. The whole study will last for a minimum of 5 weeks and a maximum of 10 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Hepatic Impairment, COVID-19

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
No hepatic impairment
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Mild hepatic impairment
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Moderate hepatic impairment
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
Severe hepatic impairment
Intervention Type
Drug
Intervention Name(s)
PF-07817883
Intervention Description
Experimental
Primary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax) of PF-07817883
Description
Plasma PF-07817883 PK parameters
Time Frame
Day 1 to Day 6
Title
Area Under the Plasma Concentration-time Profile from Time Zero to Extrapolated Infinite Time (AUCinf)
Description
Plasma PF-07817883 PK parameter
Time Frame
Day 1 to Day 6
Title
Area Under the Plasma Concentration-time Profile from Time Zero to the Time of the Last Quantifiable Concentration (AUClast)
Description
(Optional) Plasma PF-07817883 parameter
Time Frame
Day 1 to Day 6
Secondary Outcome Measure Information:
Title
Number of Participants with Non-Serious Adverse Events
Description
Safety Parameters
Time Frame
Screening to Day 35
Title
Number of Participants with Treatment Emergent Adverse Events
Description
Safety Parameters
Time Frame
Day 1 to Day 35
Title
Number of Participants with Clinically Significant ECG Abnormalities
Description
ECG parameters include QTcF, QRS, RR interval, PR interval, and Heart Rate
Time Frame
Day 1 to Day 6
Title
Number of Participants with Clinically Significant Abnormal Vital Signs
Description
Vital Signs parameters include diastolic blood pressure, systolic blood pressure, and pulse rate
Time Frame
Day 1 to Day 6
Title
Number of Participants with Clinically Significant Abnormal Laboratory Values
Description
Blood hematology and Chemistry and Urinalysis
Time Frame
Baseline to Day 6
Title
Number of Participants with Serious Adverse Events
Description
Safety Parameters
Time Frame
Screening to Day 35

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: (HI Cohorts Only): Stable HI that meets criteria for Class A or B of the Child-Pugh classification; (all Cohorts): BMI of 17.5 to 38.0 kg/m2 Exclusion Criteria: Any condition possibly affecting drug absorption Additional Exclusion Criteria for HI Cohorts Only Limited predicted life expectancy Hepatic dysfunction secondary to acute ongoing hepatocellular process. Signs of clinically active Grade 2, 3 or 4 hepatic encephalopathy. Severe ascites and/or pleural effusion History of kidney, liver, or heart transplantation. Persistent severe, uncontrolled hypertension.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
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
Anaheim Clinical Trials, LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Individual Site Status
Recruiting
Facility Name
National Institute of Clinical Research
City
Garden Grove
State/Province
California
ZIP/Postal Code
92844
Country
United States
Individual Site Status
Recruiting
Facility Name
Catalina Research Institute, LLC
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Centers of America ( Hollywood )
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
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=C5091014
Description
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A Study to Learn About How Loss of Liver Function Affects the Blood Levels of the Study Medicine Called PF-07817883.

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