Clinical trial NCT05129475: 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
Official title: A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE DOSE, 2 SEQUENCE, 2 PERIOD CROSSOVER STUDY TO EVALUATE THE EFFECT OF HIGH-FAT MEAL ON THE RELATIVE BIOAVAILABILITY OF PF-07321332 BOOSTED WITH RITONAVIR IN HEALTHY ADULT PARTICIPANTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: food effect
COVID-19 (Coronavirus disease 2019)
SARS-CoV (severe acute respiratory syndrome coronavirus)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-11-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

Primary outcomes:
measure: Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-07321332
timeFrame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose on Day 1 of Period 1 and 2
measure: Area Under the Plasma Concentration-Time Profile From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07321332
timeFrame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose on Day 1 of Period 1 and 2
measure: Maximum Observed Plasma Concentration (Cmax) of PF-07321332
timeFrame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose on Day 1 of Period 1 and 2
Secondary outcomes:
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07321332
timeFrame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose on Day 1 of Period 1 and 2
measure: Terminal Elimination Half-life (t1/2) of PF-07321332
timeFrame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose on Day 1 of Period 1 and 2
measure: Apparent Clearance (CL/F) of PF-07321332 From Plasma
timeFrame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose on Day 1 of Period 1 and 2
measure: Apparent Volume of Distribution (Vz/F) of PF-07321332
timeFrame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 48 hours post-dose on Day 1 of Period 1 and 2
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 of dosing in the study up to maximum of 35 days after last dose of study drug (approximately maximum of 40 days)
measure: Number of Participants With Clinical Laboratory Abnormalities
timeFrame: Day -1 of Period 1 up to Day 3 of Period 2 (maximum of 8 days)
measure: Number of Participants Meeting Pre-Specified Criteria for Vital Signs
timeFrame: Day 1 (pre-dose) of Period 1 up to Day 3 of Period 2 (maximum of 7 days)
measure: Number of Participants Meeting Pre-Specified Criteria for 12-Lead Electrocardiogram (ECG) Values
timeFrame: Day 1 (pre-dose) of Period 1 up to Day 3 of Period 2 (maximum of 7 days)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: New Haven Clinical Research Unit
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: