Study to Estimate the Effects of Hepatic Impairment on the Pharmacokinetics (PK) of PF-07321332

NCT05005312 | Completed Phase 1 Results FDA Drug

• 1 other identifier: C4671010
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

Brief Summary

The study is to estimate the effect of hepatic impairment on the plasma PK of PF-07321332/ritonavir. Findings from this study will be used to develop dosing recommendations so that the dose and/or dosing interval may be adjusted appropriately in the presence of hepatic impairment.

Conditions

Hepatic Impairment

Keywords

COVID-19; SARS-CoV-2

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Plasma Concentration (Cmax) of Plasma PF-07321332

  Cmax was the maximum observed plasma concentration and was directly observed from data. Concentration values below the lower limit of quantification (LLQ) were set to zero. Geometric mean analysis was on the log scale. Zero values were not included in geometric mean and geometric coefficient of variation calculation. The geometric coefficient of variation was expressed in percentage.

  Day 1 at 0 (pre-dose for PF-07321332), 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours, Day 2 at 24 and 36 hours, and Day 3 at 48 hours

• Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of Plasma PF-07321332

  AUClast was area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration. The geometric coefficient of variation was expressed in percentage.

  Day 1 at 0 (pre-dose for PF-07321332), 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours, Day 2 at 24 and 36 hours, and Day 3 at 48 hours

• Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Plasma PF-07321332

  AUCinf was defined as area under the plasma concentration-time curve from time zero to infinity. The geometric coefficient of variation was expressed in percentage.

  Day 1 at 0 (pre-dose for PF-07321332), 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours, Day 2 at 24 and 36 hours, and Day 3 at 48 hours

Secondary Outcomes (4)

• Number of Participants With an Treatment Emergent Adverse Event (TEAE)

  Up to 2 months

• Number of Participants With Abnormal Electrocardiograms (ECGs)

  Up to 2 months

• Number of Participants With Abnormal Vital Signs

  Up to 2 months

• Number of Participants With Abnormal Laboratory Assessments (Without Regard to Baseline Abnormality)

  Up to 2 months

Study Arms (2)

Cohort 1

EXPERIMENTAL

Healthy Volunteer

Drug: PF-07321332; Drug: Ritonavir

Cohort 2

EXPERIMENTAL

Hepatic Impairment

Drug: PF-07321332; Drug: Ritonavir

Interventions

PF-07321332 DRUG

Tablet

Cohort 1; Cohort 2

Ritonavir DRUG

PK Boosting agent

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants who are classically healthy having no clinically relevant abnormalities. No known or suspected hepatic impairment
• Stable hepatic impairment that meets the criteria for Class B of the Child-Pugh Classification

You may not qualify if:

• Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection).
• Participants who have been vaccinated with COVID-19 vaccines within the past week of dosing
• A positive urine drug test, for illicit drugs, at Screening
• History of sensitivity reactions to ritonavir or any of the formulation components of PF-07321332 or ritonavir.
• eGFR \<60 mL/min/1.73m2 based on the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≥ upper limit of normal (ULN) (for healthy participants); AST or ALT \> 5x ULN (for hepatic impairment participants)
• Albumin \> ULN (for healthy participants);
• Prothrombin time \> ULN (for healthy participants);
• Total bilirubin level ≥1.5 × ULN \[NOTE: Participants with a history of Gilbert syndrome (and hence elevated total bilirubin) are eligible provided direct bilirubin level is ≤ ULN).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Orange County Research Center

Tustin, California, 92780, United States

Location

Prism Research LLC dba Nucleus Network

Saint Paul, Minnesota, 55114, United States

Location

Related Links

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

MeSH Terms

Conditions

COVID-19

Interventions

nirmatrelvir; Ritonavir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 13, 2021
• Study Start: August 31, 2021
• Primary Completion: December 7, 2021
• Study Completion: December 7, 2021
• Last Updated: September 6, 2023
• Results First Posted: September 6, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)