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

• ClinicalTrials.gov Identifier: NCT05005312
• Recruitment Status: Completed
• First Posted: August 13, 2021
• Last Update Posted: January 19, 2022
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hepatic Impairment	Drug: PF-07321332; Drug: Ritonavir	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 17 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: August 31, 2021
• Actual Primary Completion Date: December 7, 2021
• Actual Study Completion Date: December 7, 2021

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Maximum observed plasma concentration (Cmax) for PF-07321332 [ Time Frame: 0 (pre-dose) to 48 hours post dose ]
2. Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Last Measurable Time (AUClast) for PF-07321332 [ Time Frame: 0 (pre-dose) up to 48 hours post-dose ]
3. Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-07321332 [ Time Frame: 0 (pre-dose) up to 48 hours post-dose ]

Secondary Outcome Measures :

1. Incidence of Treatment Emergent Adverse Events [ Time Frame: Day 1 to 35 ]
2. Incidence of Abnormal ECGs [ Time Frame: Day 1 to 35 ]
3. Incidence of Abnormal Vital Signs [ Time Frame: Day 1 to 35 ]
4. Incidence of Abnormal Laboratory Values [ Time Frame: Day 1 to 35 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Locations

United States, California

Orange County Research Center

Tustin, California, United States, 92780

United States, Minnesota

Prism Research LLC dba Nucleus Network

Saint Paul, Minnesota, United States, 55114

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT05005312
• Other Study ID Numbers: C4671010
• First Posted: August 13, 2021
• Last Update Posted: January 19, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:

COVID-19; SARS-CoV-2

Additional relevant MeSH terms:

Liver Diseases; Digestive System Diseases; Ritonavir; Nirmatrelvir; HIV Protease Inhibitors; Viral Protease Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-HIV Agents; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors