Phase 1
N=12
Drug-Drug Interaction Study Assessing Effect of Itraconazole on PF-07321332/Ritonavir in Healthy Participants
Healthy Participant
Bottom Line
View on ClinicalTrials.gov: NCT04962022 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Maximum Observed Concentration (Cmax) of PF-07321332 — 4678; 5546 ng/mL — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PF-07321332/ritonavir (Drug); Itraconazole (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Concentration (Cmax) of PF-07321332 |
4678; 5546 | 0.05 |
| PRIMARY Area Under the Plasma Concentration-time Profile From Time Zero to Time Tau (τ), Where Tau=12-hour Dosing Interval(AUCtau) for PF-07321332 |
33350; 46290 | 0.05 |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
7; 10; 0; 0 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) |
1; 2; 6; 0; 0; 1 | — |
| SECONDARY Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Findings |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Vital Signs Data - Supine Systolic Blood Pressure |
1.4; 1.5; 2.6; 3.6; 5.5; 5.3 | — |
| SECONDARY Change From Baseline in Vital Signs Data - Supine Diastolic Blood Pressure |
-0.9; 0.5; 4.1; 3.5; 4.9; 4.2 | — |
| SECONDARY Change From Baseline in Vital Signs Data - Supine Pulse Rate |
-0.5; -3.1; -2.4; -2.5; -0.8; -2.1 | — |
| SECONDARY Time for Cmax (Tmax) for PF-07321332 |
1.020; 1.700 | — |
| SECONDARY Terminal Half-life(t1/2) of PF-07321332 |
8.255; 7.793 | — |
| SECONDARY Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration(AUClast) of PF-07321332 |
41840; 74430 | — |
| SECONDARY Apparent Clearance(CL/F) of PF-07321332 |
8.990; 6.478 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) of PF-07321332 |
104.7; 72.07 | — |
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
- 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.
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Female participants must have a negative pregnancy test.
- BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb). -
Exclusion Criteria
- Positive test result for SARS-CoV-2 infection at the time of Screening or Day -1.
- 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).
- 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).
- Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
- History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed.
- 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.
Data sourced from ClinicalTrials.gov (NCT04962022). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.