Phase 1
N=12
Food Effect Study to Evaluate the Effect of High-Fat Meal on the Relative Bioavailability of PF-07321332 Boosted With Ritonavir in Healthy Adult Participants
Healthy Participants
Bottom Line
View on ClinicalTrials.gov: NCT05129475 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-07321332 — 43360; 35860 Nanogram*hour per milliliter
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PF-07321332/ritonavir (Drug); Ritonavir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-07321332 |
43360; 35860 | — |
| PRIMARY Area Under the Plasma Concentration-Time Profile From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07321332 |
44050; 36810 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of PF-07321332 |
5951; 3696 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07321332 |
2.50; 2.29 | — |
| SECONDARY Terminal Elimination Half-life (t1/2) of PF-07321332 |
7.390; 8.673 | — |
| SECONDARY Apparent Clearance (CL/F) of PF-07321332 From Plasma |
6.812; 8.148 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) of PF-07321332 |
68.77; 96.88 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
6; 5; 0; 0 | — |
| SECONDARY Number of Participants With Clinical Laboratory Abnormalities |
4; 4 | — |
| SECONDARY Number of Participants Meeting Pre-Specified Criteria for Vital Signs |
0; 0 | — |
| SECONDARY Number of Participants Meeting Pre-Specified Criteria for 12-Lead Electrocardiogram (ECG) Values |
0; 0 | — |
Summary
This is a Phase 1, open label, single dose, randomized, 2-treatment, 2-sequence, 2-period crossover study to evaluate the effect of high-fat meal on the relative bioavailability of PF-07321332 boosted with ritonavir following single dose oral administration of PF-07321332 in combination with ritonavir using 150 mg tablet formulation of PF-07321332 in healthy adult participants.
Eligibility Criteria
Inclusion Criteria
- Male and female participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs. Female participants of childbearing potential must have a negative pregnancy test.
- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
Exclusion Criteria
- Positive test result (RT-PCR) 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 brady-arrhythmias) or indicating serious underlying heart disease (eg, prolonged PR interval, cardiomyopathy, heart failure, underlying structural heart disease, Wolff Parkinson-White syndrome).
- Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
- History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (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 (NCT05129475). 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.