NCT05005312

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	PF-07321332	Tablet
DRUG	Ritonavir	PK Boosting agent

Timeline

• Start date: 2021-08-31
• Primary completion: 2021-12-07
• Completion: 2021-12-07
• First posted: 2021-08-13
• Last updated: 2023-09-06
• Results posted: 2023-09-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study