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Drug-Drug Interaction Study Assessing Effect of Itraconazole on PF-07321332/Ritonavir in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04962022
Recruitment Status : Completed
First Posted : July 14, 2021
Last Update Posted : October 12, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
The purpose of this study is to estimate the effect of a strong inhibitor of CYP3A4 (itraconazole) on the pharmacokinetics (PK) of PF-07321332/ritonavir in healthy participants.

Condition or disease Intervention/treatment Phase
Healthy Participant Drug: PF-07321332/ritonavir Drug: Itraconazole Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This is a Phase I, fixed sequnce, 2-period study to evaluate the effect of the strong CYP3A4 inhibitor, itraconazole, on the PK of PF-07321332 and ritonavir in healthy participants. A total of 12 healthy participants will be enrolled into this study.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: COVID-19: A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD CROSSOVER STUDY TO ESTIMATE THE EFFECT OF ITRACONAZOLE ON THE PHARMACOKINETICS OF PF-07321332/RITONAVIR IN HEALTHY PARTICIPANTS
Actual Study Start Date : July 20, 2021
Actual Primary Completion Date : September 30, 2021
Actual Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Period 1
PF-07321332/ritonavir orally
 Drug: PF-07321332/ritonavir
Administered orally every 12 hours for days for a total of 5 doses from Day 1 through Day 3
Experimental: Period 2
Itraconazole + PF-07321332/ritonavir orally.
 Drug: Itraconazole
Administered orally once daily for 8 days from Days 1 through 8

Drug: PF-07321332/ritonavir
Administered orally BID for 3 day for a total on 5 doses starting on Day 4 through Day 6


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) of PF-07321332/ritonavir when administered alone [ Time Frame: Period 1 - Day 1 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hour post-dose ]
  2. Cmax of PF-07321332/ritonavir when administered with itraconazole [ Time Frame: Period 2 - Day 1 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, and 72 hour post-dose ]
  3. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07321332/ritonavir when administered alone [ Time Frame: Period 1 - Day 1 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, and 48 hour post-dose ]
  4. AUCinf of PF-07321332/ritonavir when administered with itraconazole [ Time Frame: Period 2 - Day 1 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, and 72 hour post-dose ]

Secondary Outcome Measures :
  1. Assessment of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) [ Time Frame: Up to Day 49 ]
  2. Assessment of Participants With Laboratory Abnormalities [ Time Frame: Up to Day 14 ]
  3. Assessment of Participants With Vital Signs Abnormalities of PF-07321332/ritonavir [ Time Frame: Period 1 up to Day 4 ]
  4. Assessment of Participants With Vital Signs Abnormalities of PF-07321332/ritonavir with itraconazole [ Time Frame: Period 2 up to Day 9 ]
  5. Assessment of Abnormalities in Physical Examination (PE) [ Time Frame: Screening ]
  6. Assessment of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings of PF-07321332/ritonavir [ Time Frame: Period 1 up to Day 4 ]
  7. Assessment of Participants with Clinically Significant ECG findings of PF-07321332/ritonavir with itraconazole [ Time Frame: Period 2 up to Day 9 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male and female participants who are overtly healthy as determined by medical evaluation including medical history, PE, laboratory tests, vital signs and standard 12 lead ECGs.
  2. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  3. Female participants must have a negative pregnancy test.
  4. BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb). -

Exclusion Criteria:

  1. Positive test result for SARS-CoV-2 infection at the time of Screening or Day -1.
  2. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  3. Clinically relevant abnormalities requiring treatment (eg, acute myocardial infarction, unstable ischemic conditions, evidence of ventricular dysfunction, serious tachy or brady arrhythmias) or indicating serious underlying heart disease (eg, prolonged PR interval, cardiomyopathy, heart failure greater than NYHA 1, underlying structural heart disease, Wolff Parkinson-White syndrome).
  4. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
  5. History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed.
  6. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to COVID-19 pandemic (eg, contact with positive case, residence, or travel to an area with high incidence) that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04962022


Locations
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Belgium
Brussels Clinical Research Unit
Brussels, Bruxelles-capitale, Région DE, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04962022    
Other Study ID Numbers: C4671015
2021-003308-42 ( EudraCT Number )
First Posted: July 14, 2021    Key Record Dates
Last Update Posted: October 12, 2021
Last Verified: October 2021
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Drug-drug interaction
Itraconazole
CYP3A4 inhibitor
Additional relevant MeSH terms:
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Ritonavir
Itraconazole
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
Antifungal Agents
14-alpha Demethylase Inhibitors
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs