BioavailabilityPhase 1NCT05263921

Relative Bioavailability Study of PF-07321332/Ritonavir Oral Powder Relative to the Commercial Tablets in Healthy Participants

A Phase 1 study testing PF-07321332/ritonavir in people with Bioavailability, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Bioavailability
What is being tested?: PF-07321332/ritonavir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 10 Mar 2022to 19 May 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Pfizer Clinical Research Unit - New Haven
New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, CROSSOVER STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF PF-07321332/RITONAVIR ORAL POWDER IN 3 DIFFERENT DELIVERY VEHICLES RELATIVE TO THE COMMERCIAL PF-07321332/RITONAVIR TABLETS IN HEALTHY ADULT PARTICIPANTS UNDER FASTED CONDITIONS

The purpose of this study is to estimate the relative bioavailability of PF-07321332/ritonavir oral powder relative to the commercial tablet formulation under fasted condition in healthy adult participants. The study will also assess the effect of 3 different food vehicles on the relative bioavailability of the PF-07321332/ritonavir oral powder formulation as well as the safety, tolerability, and palatability of PF-07321332/ritonavir oral powder in healthy adult participants.

Conditions: Bioavailability
Being tested: PF-07321332/ritonavir
Keywords: coronavirus disease 2019 (COVID-19), severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Nirmatrelvir
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PF-07321332/ritonavirDrug
Single oral dose of PF-07321332/ritonavir under fasted conditions
PF-07321332/ritonavirDrug
Single oral dose of PF-07321332/ritonavir mixed with water under fasted conditions
PF-07321332/ritonavirDrug
Single oral dose of PF-07321332/ritonavir mixed with applesauce under fasted conditions
PF-07321332/ritonavirDrug
Single oral dose of PF-07321332/ritonavir mixed with vanilla pudding under fasted conditions

Study groups in NCT05263921
Study group	Role	What they receive
Treatment A: PF-07321332/ritonavir	Active comparator	PF-07321332 ritonavir Receives: Drug: PF-07321332/ritonavir
Treatment B: PF-07321332/ritonavir	Experimental	PF-07321332/ritonavir mixed with water Receives: Drug: PF-07321332/ritonavir
Treatment C: PF-07321332/ritonavir	Experimental	PF-07321332/ritonavir mixed with applesauce Receives: Drug: PF-07321332/ritonavir
Treatment D: PF-07321332/ritonavir	Experimental	PF-07321332/ritonavir mixed with vanilla pudding Receives: Drug: PF-07321332/ritonavir

What is being measured

The primary outcome is the main question the study is designed to answer.

AUCinf of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions
Area under the plasma concentration time profile from time 0 extrapolated to infinity (AUCinf) was measured. AUCinf was determined by AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period
AUClast of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions
Area under the plasma concentration time profile from time 0 to the time of the last quantifiable concentration (Clast) was measured. AUClast was determined by Linear/Log trapezoidal method.
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period
Cmax of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions
Maximum plasma concentration (Cmax) was measured. Cmax was observed directly from data.
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period
AUCinf of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions
Area under the plasma concentration time profile from time 0 extrapolated to infinity (AUCinf) was measured. AUCinf was determined by AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period
AUClast of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions
Area under the plasma concentration time profile from time 0 to the time of the last quantifiable concentration (Clast) was measured. AUClast was determined by Linear/Log trapezoidal method.
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period
Cmax of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions
Maximum plasma concentration (Cmax) was measured. Cmax was observed directly from data.
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period

Secondary outcomes (10)

Number of Participants With Treatment-Emergent Adverse Event
Adverse events (AEs): any untoward medical occurrence in a clinical investigation participant administered a product, without regard to relatedness. Treatment-emergent AEs (TEAEs): AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Treatment-related TEAEs were any untoward medical occurrence attributed to study intervention. Relatedness to study intervention was determined by the investigator.
Measured: Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
Number of Participants With Laboratory Abnormalities
Participants analyzed in the laboratory abnormalities were with at least one observation of the given laboratory test while on study treatment or during lag time. Number of participants with laboratory abnormalities were number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time. Hematology, chemistry, urinalysis and other (SARS-CoV-2 RT-PCR, Urine drug screening, Pregnancy test (β hCG), eGFR [CKD-EPI], aPTT, PT-INR, Fibrinogen, At Screening only: FSH, HBsAg, HBsAb, HBcAb, HCVAb, HIV) were assessed.
Measured: Screening, Period 1 Day -1, Period 4 Day 4 and early termination/discontinuation.
Number of Participants With Clinically Significant Vital Sign Values
Participants with clinically significant vital sign values were with at least one observation of vital signs, which met pre-specified criteria while on study treatment or during lag time.
Measured: Screening, Day 1 of each period and early termination/discontinuation.
Number of Participants With Clinically Significant Physical Examination Values
Participants with clinically significant physical examination values were with at least one observation of physical examination, which met pre-specified criteria while on study treatment or during lag time.
Measured: Screening and Period 1 Day -1.
Number of Participants With Clinically Significant Abnormal Electrocardiogram Values
Participants with clinically significant electrocardiogram (ECG) values were with at least one observation of ECG, which met pre-specified criteria while on study treatment or during lag time.
Measured: Screening, Period 1 Day 1 and Period 4 Day 4.
Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
Participants reviewed the taste questionnaire and instructions prior to the first taste assessment to treatments (B, C, D) on Period 1 Day 1. Each participant completed the Taste Assessment Survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of PF-07321332/ritonavir oral powder. For the taste assessment in the study, the data used in the analysis were transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable.
Measured: 1, 5, 10, 20 min after tasting each study intervention on Day 1 of each period.
Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
Participants reviewed the taste questionnaire and instructions prior to the first taste assessment to treatments (B, C, D) on Period 1 Day 1. Each participant completed the Taste Assessment Survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of PF-07321332/ritonavir oral powder. For the taste assessment in the study, the data used in the analysis were transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable.
Measured: 1, 5, 10, 20 min after tasting each study intervention on Day 1 of each period.
Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
Participants reviewed the taste questionnaire and instructions prior to the first taste assessment to treatments (B, C, D) on Period 1 Day 1. Each participant completed the Taste Assessment Survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of PF-07321332/ritonavir oral powder. For the taste assessment in the study, the data used in the analysis were transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable.
Measured: 1, 5, 10, 20 min after tasting each study intervention on Day 1 of each period.
Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
Participants reviewed the taste questionnaire and instructions prior to the first taste assessment to treatments (B, C, D) on Period 1 Day 1. Each participant completed the Taste Assessment Survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of PF-07321332/ritonavir oral powder. For the taste assessment in the study, the data used in the analysis were transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable.
Measured: 1, 5, 10, 20 min after tasting each study intervention on Day 1 of each period.
Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
Participants reviewed the taste questionnaire and instructions prior to the first taste assessment to treatments (B, C, D) on Period 1 Day 1. Each participant completed the Taste Assessment Survey immediately following dosing (within 1 min) and at 5, 10, and 20 minutes post oral administration of PF-07321332/ritonavir oral powder. For the taste assessment in the study, the data used in the analysis were transcribed and rescaled to a score from 0 to 100 from the raw measurements on the Taste Assessment Questionnaire. The score of 0 was considered Favorable and the score of 100 was considered Not Favorable. Higher score means more unfavorable.
Measured: 1, 5, 10, 20 min after tasting each study intervention on Day 1 of each period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Mar 202219 May 2022

First posted3 Mar 2022
Study start10 Mar 2022
Primary completion19 May 2022
Study completion19 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for BioavailabilityStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05263921
Sponsor's protocol ID: C4671024
Status last verified: Jun 2024
First submitted: 25 Feb 2022
Last updated: 6 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, CROSSOVER STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF PF-07321332/RITONAVIR ORAL POWDER IN 3 DIFFERENT DELIVERY VEHICLES RELATIVE TO THE COMMERCIAL PF-07321332/RITONAVIR TABLETS IN HEALTHY ADULT PARTICIPANTS UNDER FASTED CONDITIONS
ClinicalTrials.gov ID: NCT05263921
Acronym / sponsor ID: C4671024
Conditions: Bioavailability
Keywords: coronavirus disease 2019 (COVID-19), severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Nirmatrelvir
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 10 Mar 2022 (actual)
Primary completion: 19 May 2022 (actual)
Study completion: 19 May 2022 (actual)
First posted: 3 Mar 2022 (actual)
Results: Posted 6 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Treatment A: PF-07321332/ritonavir	Active comparator	Drug: PF-07321332/ritonavirPF-07321332 ritonavir
Treatment B: PF-07321332/ritonavir	Experimental	Drug: PF-07321332/ritonavirPF-07321332/ritonavir mixed with water
Treatment C: PF-07321332/ritonavir	Experimental	Drug: PF-07321332/ritonavirPF-07321332/ritonavir mixed with applesauce
Treatment D: PF-07321332/ritonavir	Experimental	Drug: PF-07321332/ritonavirPF-07321332/ritonavir mixed with vanilla pudding

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PF-07321332/ritonavirSingle oral dose of PF-07321332/ritonavir under fasted conditions	Drug	Treatment A: PF-07321332/ritonavir
PF-07321332/ritonavirSingle oral dose of PF-07321332/ritonavir mixed with water under fasted conditions	Drug	Treatment B: PF-07321332/ritonavir
PF-07321332/ritonavirSingle oral dose of PF-07321332/ritonavir mixed with applesauce under fasted conditions	Drug	Treatment C: PF-07321332/ritonavir
PF-07321332/ritonavirSingle oral dose of PF-07321332/ritonavir mixed with vanilla pudding under fasted conditions	Drug	Treatment D: PF-07321332/ritonavir

Primary outcome

AUCinf of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period
Area under the plasma concentration time profile from time 0 extrapolated to infinity (AUCinf) was measured. AUCinf was determined by AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.
AUClast of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period
Area under the plasma concentration time profile from time 0 to the time of the last quantifiable concentration (Clast) was measured. AUClast was determined by Linear/Log trapezoidal method.
Cmax of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period
Maximum plasma concentration (Cmax) was measured. Cmax was observed directly from data.
AUCinf of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period
Area under the plasma concentration time profile from time 0 extrapolated to infinity (AUCinf) was measured. AUCinf was determined by AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.
AUClast of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period
Area under the plasma concentration time profile from time 0 to the time of the last quantifiable concentration (Clast) was measured. AUClast was determined by Linear/Log trapezoidal method.
Cmax of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period
Maximum plasma concentration (Cmax) was measured. Cmax was observed directly from data.

10 secondary outcomes

Number of Participants With Treatment-Emergent Adverse Event
Time frame: Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.
Number of Participants With Laboratory Abnormalities
Time frame: Screening, Period 1 Day -1, Period 4 Day 4 and early termination/discontinuation.
Number of Participants With Clinically Significant Vital Sign Values
Time frame: Screening, Day 1 of each period and early termination/discontinuation.
Number of Participants With Clinically Significant Physical Examination Values
Time frame: Screening and Period 1 Day -1.
Number of Participants With Clinically Significant Abnormal Electrocardiogram Values
Time frame: Screening, Period 1 Day 1 and Period 4 Day 4.
Taste Assessment of Mouth Feel After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
Time frame: 1, 5, 10, 20 min after tasting each study intervention on Day 1 of each period.
Taste Assessment of Bitterness After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
Time frame: 1, 5, 10, 20 min after tasting each study intervention on Day 1 of each period.
Taste Assessment of Tongue/Mouth Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
Time frame: 1, 5, 10, 20 min after tasting each study intervention on Day 1 of each period.
Taste Assessment of Throat Burn After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
Time frame: 1, 5, 10, 20 min after tasting each study intervention on Day 1 of each period.
Taste Assessment of Overall Liking After Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles
Time frame: 1, 5, 10, 20 min after tasting each study intervention on Day 1 of each period.

Results and safety

Results posted to the registry on 6 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1: Treatment A-> B-> C-> D	3	3
Sequence 2: Treatment B-> D-> A-> C	3	3
Sequence 3: Treatment C-> A-> D-> B	3	2
Sequence 4: Treatment D-> C-> B-> A	3	3

Primary outcome: AUCinf of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions

Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram*hour per milliliter (ng*hr/mL)

Measure	Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets n = 11	Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water n = 11	Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce n = 12	Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding n = 11
Value	28670 (36)	30780 (25)	33170 (33)	36020 (27)

Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets vs Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water: Ratio (%) of Adjusted Geometric means: 107.35 (90% CI 99.66 to 115.64)
Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets vs Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce: Ratio (%) of Adjusted Geometric Means: 120.73 (90% CI 112.09 to 130.03)
Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets vs Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding: Ratio (%) of Adjusted Geometric Means: 125.04 (90% CI 116.08 to 134.69)

Population analysed: The analysis population refers to all participants dosed who had at least 1 of the PK parameters of primary interest.

Primary outcome: AUClast of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions

Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets n = 11	Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water n = 11	Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce n = 12	Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding n = 11
Value	27790 (36)	30230 (27)	32180 (33)	35580 (27)

Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets vs Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water: Ratio (%) of Adjusted Geometric means: 108.80 (90% CI 101.06 to 117.14)
Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets vs Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce: Ratio (%) of Adjusted Geometric Means: 120.95 (90% CI 112.36 to 130.20)
Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets vs Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding: Ratio (%) of Adjusted Geometric Means: 127.39 (90% CI 118.32 to 137.15)

Population analysed: The analysis population refers to all participants dosed who had at least 1 of the PK parameters of primary interest.

Primary outcome: Cmax of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions

Measure	Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets n = 11	Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water n = 11	Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce n = 12	Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding n = 11
Value	2817 (31)	3254 (23)	4025 (22)	4572 (19)

Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets vs Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water: Ratio (%) of Adjusted Geometric means: 115.10 (90% CI 104.03 to 127.34)
Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets vs Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce: Ratio (%) of Adjusted Geometric Means: 145.60 (90% CI 131.68 to 160.99)
Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets vs Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding: Ratio (%) of Adjusted Geometric Means: 161.48 (90% CI 145.95 to 178.66)

Population analysed: The analysis population refers to all participants dosed who had at least 1 of the PK parameters of primary interest.

Primary outcome: AUCinf of Ritonavir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions

Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets n = 11	Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water n = 11	Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce n = 12	Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding n = 11
Value	4843 (28)	5414 (30)	4979 (45)	5271 (26)

Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets vs Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water: Ratio (%) of Adjusted Geometric means: 110.85 (90% CI 95.38 to 128.82)
Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets vs Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce: Ratio (%) of Adjusted Geometric Means: 106.55 (90% CI 91.76 to 123.73)
Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets vs Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding: Ratio (%) of Adjusted Geometric Means: 107.74 (90% CI 92.70 to 125.21)

Population analysed: The analysis population refers to all participants dosed who had at least 1 of the PK parameters of primary interest.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to Follow-up (35 days after last dose administration), an average of 10 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nirmatrelvir/Ritonavir 300/100 mg Commercial Tablets	0 of 11 (0%)	6 of 11 (54.5%)	0 of 11
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Water	0 of 11 (0%)	2 of 11 (18.2%)	0 of 11
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Applesauce	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
Nirmatrelvir/Ritonavir 300/100 mg Oral Powder Mixed With Vanilla Pudding	0 of 11 (0%)	4 of 11 (36.4%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-07321332/ritonavir in people with Bioavailability, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUCinf of Nirmatrelvir Following the Administration of Nirmatrelvir/Ritonavir in Different Delivery Vehicles Under Fasted Conditions (time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 1 of each period). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05263921.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.