Clinical trial NCT05005312: Study to Estimate the Effects of Hepatic Impairment on the Pharmacokinetics (PK) of PF-07321332
Official title: A PHASE 1, NON-RANDOMIZED, OPEN-LABEL STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-07321332 BOOSTED WITH RITONAVIR IN ADULT PARTICIPANTS WITH MODERATE HEPATIC IMPAIRMENT AND HEALTHY PARTICIPANTS WITH NORMAL HEPATIC FUNCTION
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Keywords: COVID-19
SARS-CoV-2
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-08-13
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Plasma PF-07321332
timeFrame: 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
measure: Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of Plasma PF-07321332
timeFrame: 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
measure: Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Plasma PF-07321332
timeFrame: 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:
measure: Number of Participants With an Treatment Emergent Adverse Event (TEAE)
timeFrame: Up to 2 months
measure: Number of Participants With Abnormal Electrocardiograms (ECGs)
timeFrame: Up to 2 months
measure: Number of Participants With Abnormal Vital Signs
timeFrame: Up to 2 months
measure: Number of Participants With Abnormal Laboratory Assessments (Without Regard to Baseline Abnormality)
timeFrame: Up to 2 months
Other outcomes:
Locations:
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Saint Paul
country: United States
facility: Prism Research LLC dba Nucleus Network
state: Minnesota
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: