search
Back to results

A Study to Compare How the Study Medicine (PF-07923568) is Processed in Participants With Different Levels of Loss of Liver Function to Healthy Participants.

Primary Purpose

Liver Diseases, Hepatic Impairment

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PF-07923568
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Liver Diseases focused on measuring healthy volunteers

Eligibility Criteria

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

Inclusion Criteria: for healthy volunteers: BMI of 17.5 to 38.0 kg/m2, inclusive, and a total body weight >50 kg (110 lb). Capable of giving signed informed consent. At screening, no clinically relevant abnormalities identified by a detailed medical history, complete physical examination, including BP and pulse rate measurement, standard 12-lead ECG and clinical laboratory tests. body weight within +/-15 kg of the average of pooled hepatic impaired group and +/- 10 years of the average pooled hepatic impairment group. --Exclusion criteria for all participants: Any condition or surgery possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection) Positive HIV antibodies Positive drug or alcohol test eGFR <60 mL/min/1.73m2 at screening Exclusion criteria for non-healthy participants who have hepatic impairment: Stable concomitant meds and hepatic impairment with no change in the last 28 days Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy (defined as <1 year). A diagnosis of hepatic dysfunction secondary to any acute ongoing hepatocellular process that is documented by medical history, PE, liver biopsy, hepatic ultrasound, CT scan, or MRI. History of gastrointestinal hemorrhage due to esophageal varices or peptic ulcers less than 4 weeks prior to screening. --Severe ascites and/or pleural effusion, except for those categorized as severe hepatic impairment who may be enrolled provided participant is medically stable, per the investigators' medical judgment. Previously received a kidney, liver, or heart transplant. ALT/AST greater than 5X upper limit normal

Sites / Locations

  • Orange County Research CenterRecruiting
  • Orlando Clinical Research CenterRecruiting
  • Genesis Clinical Research, LLCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Healthy subjects

Mild Hepatic impaired subjects

Moderate hepatic impaired subjects

Severe Hepatic Impaired Subjects

Arm Description

One time dose of 4 capsules taken orally.

One time dose of 4 capsules taken orally.

One time dose of 4 capsules taken orally

One time dose of 4 capsules taken orally.

Outcomes

Primary Outcome Measures

Plasma concentrations of PF-07923568 will be listed and descriptively summarized by nominal PK sampling time and treatment.

Secondary Outcome Measures

Assessment of Treatment emergent adverse events
Number of participants with abnormal laboratory test results
Number of participants with abnormal electrocardiogram (ECG) readings
Number of participants with abnormal Vital Signs

Full Information

First Posted
April 6, 2023
Last Updated
September 15, 2023
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT05857644
Brief Title
A Study to Compare How the Study Medicine (PF-07923568) is Processed in Participants With Different Levels of Loss of Liver Function to Healthy Participants.
Official Title
A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO COMPARE THE PHARMACOKINETICS OF PF-07923568 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2023 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (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 this study is to learn how the study medicine (PF-07923568) is processed in participants with liver function loss compared to healthy participants. The different levels of liver function loss can be mild, moderate or severe. This study is seeking participants who: are male or female of 18 years of age or older. are examined to be healthy (group with no loss of liver function). have mild, moderate, and severe liver disease (group with loss of liver function). All participants will receive a one-time dose of 4 capsules of PF-07923568 which will be taken by mouth. All participants will remain at the study clinic for 6 days for safety review and laboratory collections. This is to see how the study medicine is being broken down by the liver over time. All participants selected in the study will be required to go through a screening period up to 28 days. A screening period is the time during which a few participants are examined to see whether they are fit for the study. During this period, the participant's medical history and past and current medications will be reviewed. A series of tests will also be performed to see if they are good to be selected for the study. If the participant meets all required criteria and are interested in continuing, the participant will be brought into the study clinic to stay overnight for 6 days. On day 6, the participant will be discharged. About 28 to 35 days after discharge, the participant will be contacted for a follow up visit either in person or by telephone. This is to check up on how the participant is doing and to conclude the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Diseases, Hepatic Impairment
Keywords
healthy volunteers

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
An open-label, single dose, parallel group, multicenter study to investigate the effect of varying degrees of hepatic function on the plasma PK of PF-07923568 after a single, oral 200 mg dose administered in the fed state (standard breakfast).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy subjects
Arm Type
Experimental
Arm Description
One time dose of 4 capsules taken orally.
Arm Title
Mild Hepatic impaired subjects
Arm Type
Experimental
Arm Description
One time dose of 4 capsules taken orally.
Arm Title
Moderate hepatic impaired subjects
Arm Type
Experimental
Arm Description
One time dose of 4 capsules taken orally
Arm Title
Severe Hepatic Impaired Subjects
Arm Type
Experimental
Arm Description
One time dose of 4 capsules taken orally.
Intervention Type
Drug
Intervention Name(s)
PF-07923568
Other Intervention Name(s)
Sisunatovir
Intervention Description
One time dose of 4 capsules taken orally.
Primary Outcome Measure Information:
Title
Plasma concentrations of PF-07923568 will be listed and descriptively summarized by nominal PK sampling time and treatment.
Time Frame
6 days
Secondary Outcome Measure Information:
Title
Assessment of Treatment emergent adverse events
Time Frame
6 weeks
Title
Number of participants with abnormal laboratory test results
Time Frame
6 weeks
Title
Number of participants with abnormal electrocardiogram (ECG) readings
Time Frame
6 weeks
Title
Number of participants with abnormal Vital Signs
Time Frame
6 weeks

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: for healthy volunteers: BMI of 17.5 to 38.0 kg/m2, inclusive, and a total body weight >50 kg (110 lb). Capable of giving signed informed consent. At screening, no clinically relevant abnormalities identified by a detailed medical history, complete physical examination, including BP and pulse rate measurement, standard 12-lead ECG and clinical laboratory tests. body weight within +/-15 kg of the average of pooled hepatic impaired group and +/- 10 years of the average pooled hepatic impairment group. --Exclusion criteria for all participants: Any condition or surgery possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection) Positive HIV antibodies Positive drug or alcohol test eGFR <60 mL/min/1.73m2 at screening Exclusion criteria for non-healthy participants who have hepatic impairment: Stable concomitant meds and hepatic impairment with no change in the last 28 days Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy (defined as <1 year). A diagnosis of hepatic dysfunction secondary to any acute ongoing hepatocellular process that is documented by medical history, PE, liver biopsy, hepatic ultrasound, CT scan, or MRI. History of gastrointestinal hemorrhage due to esophageal varices or peptic ulcers less than 4 weeks prior to screening. --Severe ascites and/or pleural effusion, except for those categorized as severe hepatic impairment who may be enrolled provided participant is medically stable, per the investigators' medical judgment. Previously received a kidney, liver, or heart transplant. ALT/AST greater than 5X upper limit normal
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
Orange County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Individual Site Status
Recruiting
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Individual Site Status
Recruiting
Facility Name
Genesis Clinical Research, LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
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=C5241012
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study to Compare How the Study Medicine (PF-07923568) is Processed in Participants With Different Levels of Loss of Liver Function to Healthy Participants.

We'll reach out to this number within 24 hrs