Study to Estimate the Effects of Hepatic Impairment on the Pharmacokinetics (PK) of PF-07321332
Completed · Phase 1
Conditions studied: Hepatic Impairment
In brief
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.
Key facts
- Study ID
- NCT05005312
- Run by
- Pfizer
- People needed
- 17
- Starts
- 2021-08-31
- Expected to finish
- 2021-12-07
- Last updated by the study team
- 2023-09-06
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
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).
Where it is running
- Orange County Research Center — Tustin, California, United States
- Prism Research LLC dba Nucleus Network — Saint Paul, Minnesota, United States
Full record on ClinicalTrials.gov
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