Biological AvailabilityPhase 1NCT05525910

Relative Bioavailability Study of Nirmatrelvir/Ritonavir 4 Different Fixed Dose Combination Tablets Relative to the Commercial Tablets in Healthy Participants

A Phase 1 study testing Nirmatrelvir/ ritonavir and Nirmatrelvir/ritonavir in people with Biological Availability and Healthy Participants, 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

The purpose of this study is to estimate the relative bioavailability of nirmatrelvir/ritonavir of 4 different FDC tablet formulations relative to the commercial tablet formulation under fasted conditions in healthy adult participants. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Biological Availability, Healthy Participants
What is being tested?: Nirmatrelvir/ ritonavir and Nirmatrelvir/ritonavir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 31 Aug 2022to 7 Nov 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

New Haven Clinical Research Unit
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 Nirmatrelvir and Ritonavir Following Oral Administration of 4 Different Fixed Dose Combination Tablet Formulations Relative to The Commercial Tablet Formulation in Healthy Adult Participants Under Fasted Conditions

Conditions: Biological Availability, Healthy Participants
Being tested: Nirmatrelvir/ ritonavir, Nirmatrelvir/ritonavir
Keywords: Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Nirmatrelvir, Paxlovid
Medical subject headings: COVID-19

What participants receive

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

Nirmatrelvir/ ritonavirDrug
Single oral dose of nirmatrelvir/ritonavir tablets under fasted condition
Nirmatrelvir/ritonavirDrug
Single oral dose of nirmatrelvir/ritonavir tablets under fasted condition
Nirmatrelvir/ritonavirDrug
Single oral dose of nirmatrelvir/ritonavir tablets under fasted condition
Nirmatrelvir/ ritonavirDrug
Single oral dose of nirmatrelvir/ritonavir tablets under fasted condition
Nirmatrelvir/ ritonavirDrug
Single oral dose of nirmatrelvir/ritonavir tablets under fasted condition

Study groups in NCT05525910
Study group	Role	What they receive
Treatment A: Nirmatrelvir/ritonavir	Active comparator	Nirmatrelvir and ritonavir tablets Receives: Drug: Nirmatrelvir/ ritonavir
Treatment B: Nirmatrelvir/ ritonavir	Experimental	Nirmatrelvir/ ritonavir test tablets Receives: Drug: Nirmatrelvir/ritonavir
Treatment C: Nirmatrelvir/ ritonavir	Experimental	Nirmatrelvir/ ritonavir test tablets Receives: Drug: Nirmatrelvir/ritonavir
Treatment D: Nirmatrelvir/ ritonavir	Experimental	Nirmatrelvir/ ritonavir test tablets Receives: Drug: Nirmatrelvir/ ritonavir
Treatment E: Nirmatrelvir/ ritonavir	Experimental	Nirmatrelvir/ ritonavir test tablets Receives: Drug: Nirmatrelvir/ 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 4 Different Nirmatrelvir/Ritonavir FDC Tablets (Test Formulations) Compared to the Nirmatrelvir/Ritonavir 300(2*150)/100 mg Tablets (Reference Formulation)
AUCinf was defined as area under the plasma concentration-time profile from time 0 extrapolated to infinite time. AUCinf for nirmatrelvir was calculated by AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.
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 treatment period
AUClast of Nirmatrelvir Following the Administration of 4 Different Nirmatrelvir/Ritonavir FDC Tablets (Test Formulations) Compared to the Nirmatrelvir/Ritonavir 300(2*150)/100 mg Tablets (Reference Formulation)
AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast). AUClast for nirmatrelvir was calculated 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 treatment period
Cmax of Nirmatrelvir Following the Administration of 4 Different Nirmatrelvir/Ritonavir FDC Tablets (Test Formulations) Compared to the Nirmatrelvir/Ritonavir 300(2*150)/100 mg Tablets (Reference Formulation)
Cmax was defined as maximum plasma concentration. Cmax for nirmatrelvir 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 treatment period
AUCinf of Ritonavir Following the Administration of 4 Different Nirmatrelvir/Ritonavir FDC Tablets (Test Formulations) Compared to the Nirmatrelvir/Ritonavir 300(2*150)/100 mg Tablets (Reference Formulation)
AUCinf was defined as area under the plasma concentration-time profile from time 0 extrapolated to infinite time. AUCinf for ritonavir was calculated by AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.
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 treatment period
AUClast of Ritonavir Following the Administration of 4 Different Nirmatrelvir/Ritonavir FDC Tablets (Test Formulations) Compared to the Nirmatrelvir/Ritonavir 300(2*150)/100 mg Tablets (Reference Formulation)
AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast). AUClast for ritonavir was calculated 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 treatment period
Cmax of Ritonavir Following the Administration of 4 Different Nirmatrelvir/Ritonavir FDC Tablets (Test Formulations) Compared to the Nirmatrelvir/Ritonavir 300(2*150)/100 mg Tablets (Reference Formulation)
Cmax was defined as maximum plasma concentration. Cmax for ritonavir 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 treatment period

Secondary outcomes (5)

Number of Participants With All-Causality and Treatment-Related TEAEs
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Relatedness to study treatment was assessed by the investigator. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study treatment and up to approximately 51 days that were absent before treatment or that worsened relative to pretreatment state.
Measured: From the first dose of study treatment up to 35 days after last dose of study treatment (ie, up to 51 days)
Number of Participants With Clinically Significant Laboratory Abnormalities in Hematology, Chemistry, and Urinalysis
Hematology included hemoglobin, hematocrit, red blood cell, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet and white blood cell count, total neutrophils, eosinophils, etc. Chemistry included blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, fibrinogen, etc. Urinalysis included pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy and culture. Clinical significance was judged by the investigator and those met the criteria of AE are listed here. Clinically significant laboratory abnormalities reported for at least 1 participant in the whole study are presented here. Baseline was defined as the last measurement taken prior to first dosing (Period 1 Day -1).
Measured: From baseline up to Day 4 of Period 4 (approximately 17 days)
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Vital signs (temperature, pulse rate and blood pressure) were obtained with participants following at least 5 minutes of supine rest. Clinical significance of vital signs was determined at the investigator's discretion. Baseline was defined as pre-dose measurement taken on Day 1 of each period.
Measured: From baseline up to Day 4 of Period 4 (approximately 16 days)
Number of Participants With Clinically Significant Physical Examination Values
A complete physical examination (PE) included, at a minimum, height, weight, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and neurological systems. A brief PE included, at a minimum, assessments of general appearance, the respiratory and cardiovascular systems, and participant-reported symptoms. Clinical significance of physical examination values was determined at the investigator's discretion.
Measured: From baseline up to 35 days after last dose of study treatment (ie, up to 51 days)
Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG)
A 12-lead ECG was obtained using an ECG machine that automatically calculated the heart rate and measured pulse rate, QT, and QTc intervals and QRS complex. All scheduled ECGs were performed after the participant had rested quietly for at least 5 minutes in a supine position. Clinical significance of ECG values was determined at the investigator's discretion. Baseline was defined as pre-dose measurement taken on Day 1 of Period 1.
Measured: From baseline up to Day 4 of Period 4 (approximately 16 days)

Timeline

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

31 Aug 20227 Nov 2022

First posted2 Sep 2022
Study start31 Aug 2022
Primary completion7 Nov 2022
Study completion7 Nov 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 Biological AvailabilityStudies 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: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05525910
Sponsor's protocol ID: C4671023
Status last verified: Apr 2024
First submitted: 31 Aug 2022
Last updated: 19 Sep 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 19 Sep 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 Nirmatrelvir and Ritonavir Following Oral Administration of 4 Different Fixed Dose Combination Tablet Formulations Relative to The Commercial Tablet Formulation in Healthy Adult Participants Under Fasted Conditions
ClinicalTrials.gov ID: NCT05525910
Acronym / sponsor ID: C4671023
Conditions: Biological Availability, Healthy Participants
Keywords: Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Nirmatrelvir, Paxlovid
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 31 Aug 2022 (actual)
Primary completion: 7 Nov 2022 (actual)
Study completion: 7 Nov 2022 (actual)
First posted: 2 Sep 2022 (actual)
Results: Posted 19 Sep 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: 5

Arm	Type	Receives
Treatment A: Nirmatrelvir/ritonavir	Active comparator	Drug: Nirmatrelvir/ ritonavirNirmatrelvir and ritonavir tablets
Treatment B: Nirmatrelvir/ ritonavir	Experimental	Drug: Nirmatrelvir/ritonavirNirmatrelvir/ ritonavir test tablets
Treatment C: Nirmatrelvir/ ritonavir	Experimental	Drug: Nirmatrelvir/ritonavirNirmatrelvir/ ritonavir test tablets
Treatment D: Nirmatrelvir/ ritonavir	Experimental	Drug: Nirmatrelvir/ ritonavirNirmatrelvir/ ritonavir test tablets
Treatment E: Nirmatrelvir/ ritonavir	Experimental	Drug: Nirmatrelvir/ ritonavirNirmatrelvir/ ritonavir test tablets

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
Nirmatrelvir/ ritonavirSingle oral dose of nirmatrelvir/ritonavir tablets under fasted condition	Drug	Treatment A: Nirmatrelvir/ritonavir
Nirmatrelvir/ritonavirSingle oral dose of nirmatrelvir/ritonavir tablets under fasted condition	Drug	Treatment B: Nirmatrelvir/ ritonavir
Nirmatrelvir/ritonavirSingle oral dose of nirmatrelvir/ritonavir tablets under fasted condition	Drug	Treatment C: Nirmatrelvir/ ritonavir
Nirmatrelvir/ ritonavirSingle oral dose of nirmatrelvir/ritonavir tablets under fasted condition	Drug	Treatment D: Nirmatrelvir/ ritonavir
Nirmatrelvir/ ritonavirSingle oral dose of nirmatrelvir/ritonavir tablets under fasted condition	Drug	Treatment E: Nirmatrelvir/ ritonavir

Primary outcome

AUCinf of Nirmatrelvir Following the Administration of 4 Different Nirmatrelvir/Ritonavir FDC Tablets (Test Formulations) Compared to the Nirmatrelvir/Ritonavir 300(2*150)/100 mg Tablets (Reference Formulation)
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 treatment period
AUCinf was defined as area under the plasma concentration-time profile from time 0 extrapolated to infinite time. AUCinf for nirmatrelvir was calculated by AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.
AUClast of Nirmatrelvir Following the Administration of 4 Different Nirmatrelvir/Ritonavir FDC Tablets (Test Formulations) Compared to the Nirmatrelvir/Ritonavir 300(2*150)/100 mg Tablets (Reference Formulation)
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 treatment period
AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast). AUClast for nirmatrelvir was calculated by Linear/Log trapezoidal method.
Cmax of Nirmatrelvir Following the Administration of 4 Different Nirmatrelvir/Ritonavir FDC Tablets (Test Formulations) Compared to the Nirmatrelvir/Ritonavir 300(2*150)/100 mg Tablets (Reference Formulation)
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 treatment period
Cmax was defined as maximum plasma concentration. Cmax for nirmatrelvir was observed directly from data.
AUCinf of Ritonavir Following the Administration of 4 Different Nirmatrelvir/Ritonavir FDC Tablets (Test Formulations) Compared to the Nirmatrelvir/Ritonavir 300(2*150)/100 mg Tablets (Reference Formulation)
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 treatment period
AUCinf was defined as area under the plasma concentration-time profile from time 0 extrapolated to infinite time. AUCinf for ritonavir was calculated by AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.
AUClast of Ritonavir Following the Administration of 4 Different Nirmatrelvir/Ritonavir FDC Tablets (Test Formulations) Compared to the Nirmatrelvir/Ritonavir 300(2*150)/100 mg Tablets (Reference Formulation)
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 treatment period
AUClast was defined as area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast). AUClast for ritonavir was calculated by Linear/Log trapezoidal method.
Cmax of Ritonavir Following the Administration of 4 Different Nirmatrelvir/Ritonavir FDC Tablets (Test Formulations) Compared to the Nirmatrelvir/Ritonavir 300(2*150)/100 mg Tablets (Reference Formulation)
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 treatment period
Cmax was defined as maximum plasma concentration. Cmax for ritonavir was observed directly from data.

5 secondary outcomes

Number of Participants With All-Causality and Treatment-Related TEAEs
Time frame: From the first dose of study treatment up to 35 days after last dose of study treatment (ie, up to 51 days)
Number of Participants With Clinically Significant Laboratory Abnormalities in Hematology, Chemistry, and Urinalysis
Time frame: From baseline up to Day 4 of Period 4 (approximately 17 days)
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: From baseline up to Day 4 of Period 4 (approximately 16 days)
Number of Participants With Clinically Significant Physical Examination Values
Time frame: From baseline up to 35 days after last dose of study treatment (ie, up to 51 days)
Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG)
Time frame: From baseline up to Day 4 of Period 4 (approximately 16 days)

Results and safety

Results posted to the registry on 19 Sep 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-> C-> D-> E	3	3
Sequence 3: Treatment C-> D-> E-> A	3	3
Sequence 4: Treatment D-> E-> A-> B	3	3
Sequence 5: Treatment E-> A-> B-> C	3	3

Primary outcome: AUCinf of Nirmatrelvir Following the Administration of 4 Different Nirmatrelvir/Ritonavir FDC Tablets (Test Formulations) Compared to the Nirmatrelvir/Ritonavir 300(2*150)/100 mg Tablets (Reference Formulation)

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 treatment period. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram*hour per milliliter (ng*hr/mL)

Measure	Nirmatrelvir/Ritonavir 300(2*150)/100 mg n = 11	Nirmatrelvir/Ritonavir 2*(150/50 mg) Low Disintegrant n = 11	Nirmatrelvir/Ritonavir 2*(150/50 mg) High Disintegrant n = 11	Nirmatrelvir/Ritonavir 2*(150/50 mg) HDL n = 12	Nirmatrelvir/Ritonavir 3*(100/33.3 mg) n = 12
Value	27040 (36)	29350 (28)	30680 (21)	28200 (40)	33660 (29)

Nirmatrelvir/Ritonavir 300(2*150)/100 mg vs Nirmatrelvir/Ritonavir 2*(150/50 mg) Low Disintegrant: Ratio (%) of Adjusted Geometric Means: 105.03 (90% CI 94.54 to 116.68)
Nirmatrelvir/Ritonavir 300(2*150)/100 mg vs Nirmatrelvir/Ritonavir 2*(150/50 mg) High Disintegrant: Ratio (%) of Adjusted Geometric Means: 109.15 (90% CI 98.08 to 121.47)
Nirmatrelvir/Ritonavir 300(2*150)/100 mg vs Nirmatrelvir/Ritonavir 2*(150/50 mg) HDL: Ratio of Adjusted Geometric Means: 100.72 (90% CI 90.79 to 111.74)

Population analysed: All participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of primary interest were reported.

Primary outcome: AUClast of Nirmatrelvir Following the Administration of 4 Different Nirmatrelvir/Ritonavir FDC Tablets (Test Formulations) Compared to the Nirmatrelvir/Ritonavir 300(2*150)/100 mg Tablets (Reference Formulation)

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 treatment period. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	Nirmatrelvir/Ritonavir 300(2*150)/100 mg n = 11	Nirmatrelvir/Ritonavir 2*(150/50 mg) Low Disintegrant n = 11	Nirmatrelvir/Ritonavir 2*(150/50 mg) High Disintegrant n = 11	Nirmatrelvir/Ritonavir 2*(150/50 mg) HDL n = 12	Nirmatrelvir/Ritonavir 3*(100/33.3 mg) n = 12
Value	26620 (37)	28890 (28)	30350 (21)	27630 (42)	33060 (31)

Nirmatrelvir/Ritonavir 300(2*150)/100 mg vs Nirmatrelvir/Ritonavir 2*(150/50 mg) Low Disintegrant: Ratio (%) of Adjusted Geometric Means: 104.86 (90% CI 93.78 to 117.24)
Nirmatrelvir/Ritonavir 300(2*150)/100 mg vs Nirmatrelvir/Ritonavir 2*(150/50 mg) High Disintegrant: Ratio (%) of Adjusted Geometric Means: 109.70 (90% CI 97.93 to 122.89)
Nirmatrelvir/Ritonavir 300(2*150)/100 mg vs Nirmatrelvir/Ritonavir 2*(150/50 mg) HDL: Ratio of Adjusted Geometric Means: 100.14 (90% CI 89.69 to 111.80)

Population analysed: All participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of primary interest were reported.

Primary outcome: Cmax of Nirmatrelvir Following the Administration of 4 Different Nirmatrelvir/Ritonavir FDC Tablets (Test Formulations) Compared to the Nirmatrelvir/Ritonavir 300(2*150)/100 mg Tablets (Reference Formulation)

Measure	Nirmatrelvir/Ritonavir 300(2*150)/100 mg n = 11	Nirmatrelvir/Ritonavir 2*(150/50 mg) Low Disintegrant n = 11	Nirmatrelvir/Ritonavir 2*(150/50 mg) High Disintegrant n = 11	Nirmatrelvir/Ritonavir 2*(150/50 mg) HDL n = 12	Nirmatrelvir/Ritonavir 3*(100/33.3 mg) n = 12
Value	2709 (47)	3111 (34)	3181 (24)	3051 (42)	3556 (41)

Nirmatrelvir/Ritonavir 300(2*150)/100 mg vs Nirmatrelvir/Ritonavir 2*(150/50 mg) Low Disintegrant: Ratio (%) of Adjusted Geometric Means: 109.85 (90% CI 94.97 to 127.06)
Nirmatrelvir/Ritonavir 300(2*150)/100 mg vs Nirmatrelvir/Ritonavir 2*(150/50 mg) High Disintegrant: Ratio (%) of Adjusted Geometric Means: 114.69 (90% CI 98.92 to 132.98)
Nirmatrelvir/Ritonavir 300(2*150)/100 mg vs Nirmatrelvir/Ritonavir 2*(150/50 mg) HDL: Ratio of Adjusted Geometric Means: 109.26 (90% CI 94.64 to 126.14)

Population analysed: All participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of primary interest were reported.

Primary outcome: AUCinf of Ritonavir Following the Administration of 4 Different Nirmatrelvir/Ritonavir FDC Tablets (Test Formulations) Compared to the Nirmatrelvir/Ritonavir 300(2*150)/100 mg Tablets (Reference Formulation)

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 treatment period. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	Nirmatrelvir/Ritonavir 300(2*150)/100 mg n = 11	Nirmatrelvir/Ritonavir 2*(150/50 mg) Low Disintegrant n = 11	Nirmatrelvir/Ritonavir 2*(150/50 mg) High Disintegrant n = 11	Nirmatrelvir/Ritonavir 2*(150/50 mg) HDL n = 12	Nirmatrelvir/Ritonavir 3*(100/33.3 mg) n = 12
Value	3420 (76)	3230 (81)	3453 (54)	2921 (85)	4130 (62)

Nirmatrelvir/Ritonavir 300(2*150)/100 mg vs Nirmatrelvir/Ritonavir 2*(150/50 mg) Low Disintegrant: Ratio (%) of Adjusted Geometric Means: 88.85 (90% CI 76.24 to 103.53)
Nirmatrelvir/Ritonavir 300(2*150)/100 mg vs Nirmatrelvir/Ritonavir 2*(150/50 mg) High Disintegrant: Ratio (%) of Adjusted Geometric Means: 95.11 (90% CI 81.41 to 111.11)
Nirmatrelvir/Ritonavir 300(2*150)/100 mg vs Nirmatrelvir/Ritonavir 2*(150/50 mg) HDL: Ratio of Adjusted Geometric Means: 85.74 (90% CI 73.73 to 99.70)

Population analysed: All participants who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of primary interest were reported.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first dose of study treatment up to 35 days after last dose of study treatment (ie, up to 51 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nirmatrelvir/Ritonavir 300(2*150)/100 mg	0 of 11 (0%)	2 of 11 (18.2%)	0 of 11
Nirmatrelvir/Ritonavir 2*(150/50 mg) Low Disintegrant	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Nirmatrelvir/Ritonavir 2*(150/50 mg) High Disintegrant	0 of 11 (0%)	2 of 11 (18.2%)	0 of 11
Nirmatrelvir/Ritonavir 2*(150/50 mg) HDL	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
Nirmatrelvir/Ritonavir 3*(100/33.3 mg)	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 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 Nirmatrelvir/ ritonavir and Nirmatrelvir/ritonavir in people with Biological Availability and Healthy Participants, 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 19 Sep 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 19 Sep 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 4 Different Nirmatrelvir/Ritonavir FDC Tablets (Test Formulations) Compared to the Nirmatrelvir/Ritonavir 300(2*150)/100 mg Tablets (Reference Formulation) (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 treatment 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 NCT05525910.

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 19 Sep 2024.