Drug-Drug Interaction Study Assessing Effect of Itraconazole on PF-07321332/Ritonavir in Healthy Participants
Condition: Healthy Participant
Intervention: PF-07321332/ritonavir; Itraconazole; PF-07321332/ritonavir
Intervention description: Administered orally every 12 hours for days for a total of 5 doses from Day 1 through Day 3; Administered orally once daily for 8 days from Days 1 through 8; Administered orally BID for 3 day for a total on 5 doses starting on Day 4 through Day 6
Intervention MeSH terms: Ritonavir; Itraconazole; Nirmatrelvir
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a Phase I, fixed sequence, 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)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug-drug interaction; Itraconazole; CYP3A4 inhibitor

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.
    

Eligibility 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.