Phase 1
Completed N=12
Relative Bioavailability Study of 4 Different Formulations of PF-07321332 Relative to the Commercial Tablet Formulation
Bioavailability
Source: ClinicalTrials.gov NCT05263895 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcomePrimary: Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (Clast) (AUClast) of Nirmatrelvir — 35020; 31700; 35990; 48380 nanogram*hour per milliliter (ng*hr/mL)
Summary
The purpose of this study is to estimate the relative bioavailability of PF-07321332 in different formulations in healthy adult participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (Clast) (AUClast) of Nirmatrelvir |
35020; 31700; 35990; 48380; 10530 | — |
| PRIMARY Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Nirmatrelvir |
35540; 32430; 36420; 48680; 10580 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of Nirmatrelvir |
3347; 3155; 3635; 8840; 4871 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
4; 1; 3; 0; 1; 4 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) |
1; 0; 1; 0; 0; 1 | — |
| SECONDARY Number of Participants With Vital Signs Abnormalities |
0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With ECG Abnormalities |
0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Physical Examination Abnormalities |
0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination (PE), laboratory tests, vital signs and standard 12 lead ECGs.
- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
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 New York Heart Association (NYHA) 1, 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 B surface antibody (HCVAb). Hepatitis B vaccination is allowed.
- Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.
- Participant who have received a COVID-19 vaccine within 7 days before screening or admission, or who are to be vaccinated with a COVID-19 vaccine at any time during the study confinement period.
- A positive urine drug test.
Data sourced from ClinicalTrials.gov (NCT05263895). 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. Informational only — not medical advice.