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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT05005312
Collaborator
(none)
17
Enrollment
2
Locations
2
Arms
3.2
Actual Duration (Months)
8.5
Patients Per Site
2.6
Patients Per Site Per Month

Study Details

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
Phase 1

Study Design

Study Type:
Interventional
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 :
Aug 31, 2021
Actual Primary Completion Date :
Dec 7, 2021
Actual Study Completion Date :
Dec 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 [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 [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 [0 (pre-dose) up to 48 hours post-dose]

Secondary Outcome Measures

  1. Incidence of Treatment Emergent Adverse Events [Day 1 to 35]

  2. Incidence of Abnormal ECGs [Day 1 to 35]

  3. Incidence of Abnormal Vital Signs [Day 1 to 35]

  4. Incidence of Abnormal Laboratory Values [Day 1 to 35]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Site City State Country Postal Code
1 Orange County Research Center Tustin California United States 92780
2 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT05005312
Other Study ID Numbers:
  • C4671010
First Posted:
Aug 13, 2021
Last Update Posted:
Jan 19, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Ritonavir

Study Results

No Results Posted as of Jan 19, 2022