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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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).

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1 		Healthy Volunteer
  • Drug: PF-07321332
    Tablet
  • Drug: Ritonavir
    PK Boosting agent
Experimental
Cohort 2 		Hepatic Impairment
  • Drug: PF-07321332
    Tablet
  • Drug: Ritonavir
    PK Boosting agent

Recruiting Locations

More Details

NCT ID
NCT05005312
Status
Completed
Sponsor
Pfizer

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.