At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 12 enrolled
Drug / intervention
PF-07321332/ritonavir +4 moredrug
Likely dose
Not stated in record
Key inclusion· 3
- ✓Overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and standard 12-lead ECGs
- ✓BMI 17.5-30.5 kg/m² and total body weight >50 kg
- ✓Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and study procedures
Key exclusion· 8
- ✕Positive test for SARS-CoV-2 infection at screening or Day -1
- ✕Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease
- ✕Clinically relevant cardiac abnormalities including acute myocardial infarction, unstable ischemic conditions, ventricular dysfunction, serious arrhythmias, prolonged PR interval, cardiomyopathy, heart failure, structural heart disease, or Wolff Parkinson-White syndrome
- ✕Any condition affecting drug absorption such as gastrectomy or cholecystectomy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, CROSSOVER STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF PF-07321332 FOLLOWING ORAL ADMINISTRATION OF 4 DIFFERENT FORMULATIONS RELATIVE TO THE COMMERCIAL TABLET FORMULATION IN HEALTHY ADULT PARTICIPANTS UNDER FASTED CONDITIONS
In Brief
A Phase 1 clinical trial evaluating PF-07321332/ritonavir and PF-07321332 for Bioavailability. Completed, enrolled 12 participants across 1 site.
Detailed Summary
The purpose of this study is to estimate the relative bioavailability of PF-07321332 in different formulations in healthy adult participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBioavailability
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2023202420252026
First PostedMar 2022
Enrollment StartMar 2022
Primary CompletionMay 2022
TodayJul 2026
First PostedMar 3, 2022
Enrollment StartMar 3, 2022
Primary CompletionMay 16, 2022
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 4.3 years ago
Interventions
PF-07321332/ritonavirdrug
PF-07321332 ritonavir will be administered as single dose orally
PF-07321332/ritonavirdrug
PF-07321332 ritonavir will be administered as single oral dose orally.
PF-07321332/ritonavirdrug
PF-07321332 ritonavir will be administered as single oral dose orally.
PF-07321332/ritonavirdrug
PF-07321332 ritonavir will be administered as single oral dose orally.
PF-07321332drug
PF-07321332 will be administered as single oral dose orally.