Phase 1
N=17
Study to Estimate the Effects of Hepatic Impairment on the Pharmacokinetics (PK) of PF-07321332
Hepatic Impairment
Bottom Line
View on ClinicalTrials.gov: NCT05005312 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Maximum Observed Plasma Concentration (Cmax) of Plasma PF-07321332 — 1.886; 1.923 micrograms per milliliter (ug/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PF-07321332 (Drug); Ritonavir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Plasma PF-07321332 |
1.886; 1.923 | — |
| PRIMARY Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of Plasma PF-07321332 |
14.97; 14.86 | — |
| PRIMARY Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Plasma PF-07321332 |
15.24; 15.06 | — |
| SECONDARY Number of Participants With an Treatment Emergent Adverse Event (TEAE) |
3; 4; 0; 3 | — |
| SECONDARY Number of Participants With Abnormal Electrocardiograms (ECGs) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Abnormal Vital Signs |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With Abnormal Laboratory Assessments (Without Regard to Baseline Abnormality) |
0; 1; 1; 2; 0; 1 | — |
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 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).
Data sourced from ClinicalTrials.gov (NCT05005312). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.