HealthyPhase 1NCT06122194

A Study to Learn PF-07817883 Blood Levels After Administration of Tablets of Study Drug to Healthy Adult Volunteers

A Phase 1 study testing Drug: PF-07817883 in people with Healthy, run by Pfizer at 1 site in Belgium.

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: Healthy
What is being tested?: Drug: PF-07817883
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 siteBelgium
Study dates: 23 Nov 2023to 12 Jan 2024
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

Male and female participants aged 18 years or older, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and standard 12-lead ECG.
BMI of 16 to 32 kg/m2; and a total body weight >45 kg
Capable of giving signed informed consent.

Who cannot join

Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior, laboratory abnormality, or other conditions and situations that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
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).
Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed.
Positive test result for SARS-CoV-2 infection at admission

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, B-1070

Other trials in Belgium

About this study

Official title: A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE DOSE, CROSSOVER STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF PF-07817883 FOLLOWING ORAL ADMINISTRATION OF NEW FORMULATIONS RELATIVE TO THE REFERENCE FORMULATION IN HEALTHY ADULT PARTICIPANTS UNDER FASTED CONDITION

The purpose of this study is to estimate the oral bioavailability of 3 new formulations of PF-07817883 (test) relative to reference tablet formulation in healthy adult participants under fasted conditions. The study will also assess the safety and tolerability of test and reference tablet formulations in healthy adult participants.

Read the detailed description

This is a Phase 1, open-label, randomized, 4-period, 4-sequence crossover study in healthy adult participants evaluating the rBA of 3 new PF-07817883 test oral formulation(s) compared to PF-07817883 reference oral formulation. Approximately 12 participants will be enrolled in this study with approximately equal number of participants randomized to 1 of 4 sequences.

Conditions: Healthy
Being tested: Drug: PF-07817883

What participants receive

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

Drug: PF-07817883Drug
PF-07817883 tablet

Study groups in NCT06122194
Study group	Role	What they receive
Period 1 formulation 1 PF-07817883	Experimental	Single oral dose of PF-07817883 tablet under fasted condition Receives: Drug: Drug: PF-07817883
Period 2 formulation 2 PF-07817883	Experimental	Single oral dose of PF-07817883 tablet under fasted condition Receives: Drug: Drug: PF-07817883
Period 3 formulation 3 PF-07817883	Experimental	Single oral dose of PF-07817883 tablet under fasted condition Receives: Drug: Drug: PF-07817883
Period 4 formulation 4 PF-07817883	Experimental	Single oral dose of PF-07817883 tablet under fasted condition Receives: Drug: Drug: PF-07817883

What is being measured

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

Maximum Observed Plasma Concentration (Cmax) of PF-07817883
Measured: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post-dose on Day 1 of each treatment period
Area Under the Concentration-time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07817883
Measured: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post-dose on Day 1 of each treatment period

Secondary outcomes (4)

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. Treatment-emergent are events between first dose of study treatment and up to 28-35 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Measured: From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days)
Number of Participants With Laboratory Test Abnormalities
Laboratory parameters included hematology (eosinophils/leukocytes [%] greater than [>] 1.2*upper limit of normal), and urinalysis (urine hemoglobin and leukocyte esterase greater than or equal [>=] to 1).
Measured: From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days)
Number of Participants With Clinically Significant Abnormality in Vital Signs
Vital signs included diastolic blood pressure (DBP), systolic blood pressure (SBP) and pulse rate (PR) were measured in a supine position after approximately 5 minutes of rest for the participant. Criteria for vital signs included: SBP: value less than (<) 90 millimeters of mercury (mmHg), change from baseline greater than or equal to (>=) 30 mmHg increase, change from baseline >=30 mmHg decrease; DBP: value <50 mmHg, change from baseline >=20 mmHg increase, change from baseline >=20 mmHg decrease; PR: value <40 beats per minute (bpm), value greater than (>) 120 bpm.
Measured: From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days)
Number of Participants With Clinically Significant Abnormality in Electrocardiogram (ECG)
Standard 12 lead ECGs were obtained with the participant in a supine position after at least 5 minutes of rest. Criteria were PR interval (>=300 millisecond [msec], percent [%] change from baseline >=25 to 50%), QRS duration (>=140 msec, %change from baseline >=50%), corrected QT interval using Fridericia's formula (QTcF) (>500 msec, %change from baseline >60 msec, 450 msec<value less than equal to [<=] 480 msec, 480 msec<value<=500 msec, 30 msec<=change<=60 msec).
Measured: From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days)

Timeline

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

23 Nov 202312 Jan 2024

First posted8 Nov 2023
Study start23 Nov 2023
Primary completion12 Jan 2024
Study completion12 Jan 2024

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 HealthyStudies 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: 4 period 4 sequence crossover design
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06122194
Sponsor's protocol ID: C5091013
Other IDs: 2023-506442-24-00, 2023
Status last verified: Sep 2024
First submitted: 10 Oct 2023
Last updated: 30 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2025. 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-07817883 FOLLOWING ORAL ADMINISTRATION OF NEW FORMULATIONS RELATIVE TO THE REFERENCE FORMULATION IN HEALTHY ADULT PARTICIPANTS UNDER FASTED CONDITION
ClinicalTrials.gov ID: NCT06122194
Acronym / sponsor ID: C5091013
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 23 Nov 2023 (actual)
Primary completion: 12 Jan 2024 (actual)
Study completion: 12 Jan 2024 (actual)
First posted: 8 Nov 2023 (actual)
Results: Posted 30 Jan 2025

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4
Model description: 4 period 4 sequence crossover design

Arm	Type	Receives
Period 1 formulation 1 PF-07817883	Experimental	Drug: Drug: PF-07817883Single oral dose of PF-07817883 tablet under fasted condition
Period 2 formulation 2 PF-07817883	Experimental	Drug: Drug: PF-07817883Single oral dose of PF-07817883 tablet under fasted condition
Period 3 formulation 3 PF-07817883	Experimental	Drug: Drug: PF-07817883Single oral dose of PF-07817883 tablet under fasted condition
Period 4 formulation 4 PF-07817883	Experimental	Drug: Drug: PF-07817883Single oral dose of PF-07817883 tablet under fasted condition

Who may qualify

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

Key inclusion criteria (3 listed)

Male and female participants aged 18 years or older, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and standard 12-lead ECG.
BMI of 16 to 32 kg/m2; and a total body weight >45 kg
Capable of giving signed informed consent.

Key exclusion criteria (5 listed)

Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior, laboratory abnormality, or other conditions and situations that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
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).
Positive test result for SARS-CoV-2 infection at admission

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
Drug: PF-07817883PF-07817883 tablet	Drug	Period 1 formulation 1 PF-07817883, Period 2 formulation 2 PF-07817883, Period 3 formulation 3 PF-07817883, Period 4 formulation 4 PF-07817883

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of PF-07817883
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post-dose on Day 1 of each treatment period
Area Under the Concentration-time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07817883
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post-dose on Day 1 of each treatment period

4 secondary outcomes

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days)
Number of Participants With Laboratory Test Abnormalities
Time frame: From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days)
Number of Participants With Clinically Significant Abnormality in Vital Signs
Time frame: From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days)
Number of Participants With Clinically Significant Abnormality in Electrocardiogram (ECG)
Time frame: From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days)

Results and safety

Results posted to the registry on 30 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

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

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of PF-07817883

Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post-dose on Day 1 of each treatment period. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram per milliliter (ng/mL)

Measure	Treatment A: PF-07817883 300 mg Reference Formulation n = 11	Treatment B: PF-07817883 300 mg Test Formulation 1 n = 11	Treatment C: PF-07817883 300 mg Test Formulation 2 n = 12	Treatment D: PF-07817883 300 mg Test Formulation 3 n = 11
Value	2308 (39)	2579 (28)	4266 (40)	3566 (34)

Treatment A: PF-07817883 300 mg Reference Formulation vs Treatment B: PF-07817883 300 mg Test Formulation 1: Ratio of Adjusted Geometric Means: 112.15 (90% CI 93.01 to 135.22)
Treatment A: PF-07817883 300 mg Reference Formulation vs Treatment C: PF-07817883 300 mg Test Formulation 2: Ratio of Adjusted Geometric Means: 187.37 (90% CI 155.79 to 225.35)
Treatment A: PF-07817883 300 mg Reference Formulation vs Treatment D: PF-07817883 300 mg Test Formulation 3: Ratio of Adjusted Geometric Means: 153.61 (90% CI 127.40 to 185.21)

Population analysed: Pharmacokinetic (PK) parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of interest in at least 1 treatment period.

Primary outcome: Area Under the Concentration-time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07817883

Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 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	Treatment A: PF-07817883 300 mg Reference Formulation n = 10	Treatment B: PF-07817883 300 mg Test Formulation 1 n = 9	Treatment C: PF-07817883 300 mg Test Formulation 2 n = 10	Treatment D: PF-07817883 300 mg Test Formulation 3 n = 10
Value	17660 (35)	18200 (22)	21040 (36)	21510 (33)

Treatment A: PF-07817883 300 mg Reference Formulation vs Treatment B: PF-07817883 300 mg Test Formulation 1: Ratio of Adjusted Geometric Means: 102.59 (90% CI 91.09 to 115.54)
Treatment A: PF-07817883 300 mg Reference Formulation vs Treatment C: PF-07817883 300 mg Test Formulation 2: Ratio of Adjusted Geometric Means: 125.07 (90% CI 110.81 to 141.17)
Treatment A: PF-07817883 300 mg Reference Formulation vs Treatment D: PF-07817883 300 mg Test Formulation 3: Ratio of Adjusted Geometric Means: 121.75 (90% CI 108.65 to 136.43)

Population analysed: PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of interest in at least 1 treatment period. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A: PF-07817883 300 mg Reference Formulation	0 of 11 (0%)	2 of 11 (18.2%)	0 of 11
Treatment B: PF-07817883 300 mg Test Formulation 1	0 of 11 (0%)	2 of 11 (18.2%)	0 of 11
Treatment C: PF-07817883 300 mg Test Formulation 2	0 of 12 (0%)	3 of 12 (25%)	0 of 12
Treatment D: PF-07817883 300 mg Test Formulation 3	0 of 11 (0%)	2 of 11 (18.2%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
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 Drug: PF-07817883 in people with Healthy, run by Pfizer at 1 site in Belgium.

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 5 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 30 Jan 2025. 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 Belgium. 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 30 Jan 2025). 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?

Maximum Observed Plasma Concentration (Cmax) of PF-07817883 (time frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post-dose on Day 1 of each treatment period). The study lists 2 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 NCT06122194.

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 30 Jan 2025; AzTrials last refreshed its copy on 3 Nov 2026.