HealthyPhase 1NCT07563894
Relative Bioavailability and Impact of Rabeprazole for PF-07799933, Food-Effect for PF-07799933 and PF-07799544
A Phase 1 study testing PF-07799933 tablets with PF-07799544 fasted, PF-07799933 film-coated tablets with PF-07799544 fasted and PF-07799933 film-coated tablets with PF-07799544 fed in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the relative bioavailability (rBA) of the Form 2 film-coated tablet of PF-07799933 intended for use in future studies compared to the current Form 1 tablet of PF-07799933 used in Phase 1 studies. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-07799933 tablets with PF-07799544 fasted, PF-07799933 film-coated tablets with PF-07799544 fasted and PF-07799933 film-coated tablets with PF-07799544 fed
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2026to 26 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female participants of non-childbearing potential and male participants 18 to 65 years of age (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and ECGs.
- BMI of 16-32 kg/m2; and a total body weight >50 kg (110 lb)
Who cannot join
- Evidence or history of clinically significant uveitis, 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, chronic diarrhea, - inflammatory bowel disease).
- History of HIV infection, hepatitis B, or hepatitis C
- History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (eg,glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes); history of retinal degenerative disease (including evidence of macular degeneration); blurred vision.
- Any evidence of active bacterial, fungal, or viral infection
- Participants who have undergone major surgery ≤ 2 weeks prior to starting study treatment
Show all 21Show fewer
- Participants with known or suspected hypersensitivity to active ingredient/excipients
- Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- 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. Prior or concomitant use of proton pump inhibitors within 7 days prior to first dose of study intervention is prohibited. Also prohibited is prior or concomitant use of any medications or substances that are:
- For Cohort 1: strong or moderate inducers of CYP3A4/5, CYP2C9, or UGT2B7 within 28 days or 5 half-lives plus 10 days prior to first dose of study intervention, and strong or moderate inhibitors of CYP3A4/5, CYP2C9, UGT1A9 or UGT2B7 within 5 half-lives or 10 days (whichever is longer) prior to first dose of study intervention.
- For Cohort 2: strong or moderate inducers of UGT2B7 within 28 days or 5 half-lives plus 10 days prior to first dose of study intervention, and strong or moderate inhibitors of UGT2B7 within 5 half-lives or 10 days (whichever is longer) prior to first dose of study intervention.
- Current use of concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
- Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
- A positive urine drug test. A single repeat for positive drug screen may be allowed.
- Use of tobacco or nicotine containing products within 3 months of screening or a positive urine cotinine test (ie, active smokers and those who currently use nicotine-containing products are excluded from participation in this study).
- Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) for participants <60 years; and ≥150/90 mm Hg for participants ≥60 years old, following at least 5 minutes of supine rest. If systolic BP is ≥ 140 or 150 mm Hg (based on age) or diastolic ≥90 mm Hg, the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
- An eGFR < 60 (units of mL/min/1.73 m²) as determined by the CKD-EPI equation
- Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
- Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:
- ALT, AST, Bilirubin ≥1.5× ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN, Hemoglobin ≤ 11 g/dL ANC ≤ 1.5 × 109/L, Platelets ≤ 150,000/mm3/.
- History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Clinical Research Unit - New Haven
New Haven, Connecticut, 06511
About this study
Official title: A Phase 1 Open-Label, Single-Dose, Two Cohort Crossover Study to Evaluate the Relative Bioavailability of a Test Formulation of PF-07799933 and the Effect of a High-Fat Meal on Plasma Pharmacokinetics of PF-07799933 and PF 07799544 Administered in Combination, and the Impact of a Proton Pump Inhibitor on the Plasma Pharmacokinetics of PF-07799933, in Healthy Participants.
The purpose of this study is to evaluate the relative bioavailability (rBA) of the Form 2 film-coated tablet of PF-07799933 intended for use in future studies compared to the current Form 1 tablet of PF-07799933 used in Phase 1 studies. Additionally this study will also evaluate the effect of a high-fat meal on the plasma pharmacokinetics (PK), i.e, the rBA compared to overnight fasting, of PF-07799933 and PF-07799544 following concurrent single-dose oral administration of Form 2 film-coated tablet formulation of PF-07799933 with PF-07799544. Finally, this study will also assess the impact of a proton pump inhibitor (a type of acid reducing agent) on PF-07799933 PK of the Form 2 film-coated tablet formulation. These data will be used to inform administration of PF-07799933 and PF-07799544 with food and acid reducing agents in future clinical trials.
Read the detailed description
This is a Phase 1, open-label, randomized, single-dose, 2-cohort study: a three period two sequence crossover (Relative Bioavailability and Food Effect) cohort in healthy adult participants, and a two-period single sequence cohort (Proton Pump Inhibitor) in healthy adult participants. Cohort 1 of this study, which has 3 periods, will evaluate the impact of the Form 2 film-coated tablet of PF-07799933 (test formulation) compared to the Form 1 tablet of PF-07799933 (reference formulation) used in the C4901001 and C4761001 Phase 1 studies (Period 1 and Period 2). This cohort (Cohort 1) will also evaluate the effect of a high fat meal on plasma pharmacokinetics (ie, the relative bioavailability compared to overnight fasting) of the Form 2 film-coated tablet of PF-07799933 and of PF-07799544 following concurrent single-dose administrations of 300 mg of PF 07799933 and the optimized dose identified from an ongoing clinical study (either 7.5 or 12 mg) of PF 07799544 to healthy adult participants (Period 3). Cohort 2, which has two periods, will evaluate the plasma pharmacokinetics of PF-07799933 before (Period 1) and after administration of the proton pump inhibitor rabeprazole (20 mg BID for 3 days and once in the morning for the last dose [seven total doses]) (Period 2). Cohort 2 will be conducted using the Form 2 film-coated tablet of PF-07799933 in both periods.
- Conditions
- Healthy
- Being tested
- PF-07799933 tablets with PF-07799544 fasted, PF-07799933 film-coated tablets with PF-07799544 fasted, PF-07799933 film-coated tablets with PF-07799544 fed, PF-07799933 film-coated tablets fasted, PF-07799933 film-coated tablets following rabeprazole pretreatment fasted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-07799933 tablets with PF-07799544 fastedDrug
Participants receive Form 1 in a single dose of tablet in a single dose combination fasted
PF-07799933 film-coated tablets with PF-07799544 fastedDrug
Participants receive Form 2 in a single dose of tablet in a single dose combination fasted
PF-07799933 film-coated tablets with PF-07799544 fedDrug
Participants receive Form 2 in a single dose of tablet in a single dose combination in the fed state
PF-07799933 film-coated tablets fastedDrug
Participants receive Form 2 in a single dose of tablet fasted
PF-07799933 film-coated tablets following rabeprazole pretreatment fastedDrug
Participants receive Form 2 in a single dose of tablet following rabeprazole pre-treatment fasted
| Study group | Role | What they receive |
|---|---|---|
| PF-07799933 Form 1 Tablet Arm with PF-07799544 Fasted | Experimental | Cohort 1 Period 1: Participants receive PF-07799933 tablets in Combination With PF-07799544 Receives: Drug: PF-07799933 tablets with PF-07799544 fasted |
| PF-07799933 Form 2 Film-Coated Tablet Arm with PF-07799544 Fasted | Experimental | Cohort 1 Period 2: Participants receive PF-07799933 film-coated tablets in Combination With PF-07799544 Receives: Drug: PF-07799933 film-coated tablets with PF-07799544 fasted |
| PF-07799933 Form 2 Film-Coated Tablet Arm with PF-07799544 under Fed Conditions | Experimental | Cohort 1 Period 3: Participants receive PF-07799933 film-coated tablets in Combination With PF-07799544 following a High-Fat Meal Receives: Drug: PF-07799933 film-coated tablets with PF-07799544 fed |
| PF-07799933 Form 2 Tablet Arm | Experimental | Cohort 2 Period 1: Participants receive PF-07799933 film-coated tablets Receives: Drug: PF-07799933 film-coated tablets fasted |
| PF-07799933 Form 2 Tablet Arm following Rabeprazole Pretreatment | Experimental | Cohort 2 Period 1: Participants receive PF-07799933 film-coated tablets following rabeprazole treatment Receives: Drug: PF-07799933 film-coated tablets following rabeprazole pretreatment fasted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-07799933 Form 1 tablet when dosed in combination with PF-07799544 fasted
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-07799933 Form 2 film-coated tablet when dosed in combination with PF-07799544 fasted
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to The Last Measured Time Point (AUClast) for PF-07799933 Form 1 tablet when dosed in combination with PF-07799544 fasted
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to The Last Measured Time Point (AUClast) for PF-07799933 Form 2 film-coated tablet when dosed in combination with PF-07799544 fasted
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Maximum Observed Plasma Concentration (Cmax) for PF-07799933 Form 1 tablet when dosed in combination with PF-07799544 fasted
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Maximum Observed Plasma Concentration (Cmax) for PF-07799933 Form 2 film-coated tablet when dosed in combination with PF-07799544 fasted
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-07799933 Form 2 film-coated tablet when dosed in combination with PF-07799544 under fed conditions
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to The Last Measured Time Point (AUClast) for PF-07799933 Form 2 film-coated tablet when dosed in combination with PF-07799544 under fed conditions
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Maximum Observed Plasma Concentration (Cmax) for PF-07799933 Form 2 film-coated tablet when dosed in combination with PF-07799544 under fed conditions
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-07799544 tablet when dosed in combination with Form 2 film-coated tablet of PF-07799933 fasted
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to The Last Measured Time Point (AUClast) for PF-07799544 tablet when dosed in combination with Form 2 film-coated tablet of PF-07799933 fasted
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Maximum Observed Plasma Concentration (Cmax) for PF-07799544 tablet when dosed in combination with Form 2 film-coated tablet of PF-07799933 fasted
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-07799544 tablet when dosed in combination with Form 1 tablet of PF-07799933 fasted
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to The Last Measured Time Point (AUClast) for PF-07799544 tablet when dosed in combination with Form 1 tablet of PF-07799933 fasted
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Maximum Observed Plasma Concentration (Cmax) for PF-07799544 tablet when dosed in combination with Form 1 tablet of PF-07799933 fasted
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-07799544 tablet when dosed in combination with Form 2 film-coated tablet of PF-07799933 under fed conditions
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to The Last Measured Time Point (AUClast) for PF-07799544 tablet when dosed in combination with Form 2 film-coated tablet of PF-07799933 under fed conditions
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Maximum Observed Plasma Concentration (Cmax) for PF-07799544 tablet when dosed in combination with Form 2 film-coated tablet of PF-07799933 under fed conditions
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-07799933 Form 2 film-coated tablet when dosed fasted
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to The Last Measured Time Point (AUClast) for PF-07799933 Form 2 film-coated tablet when dosed fasted
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Maximum Observed Plasma Concentration (Cmax) for PF-07799933 Form 2 film-coated tablet when dosed fasted
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-07799933 Form 2 film-coated tablet when dosed fasted following rabeprazole pretreatment
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to The Last Measured Time Point (AUClast) for PF-07799933 Form 2 film-coated tablet when dosed fasted following rabeprazole pretreatment
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Maximum Observed Plasma Concentration (Cmax) for PF-07799933 Form 2 film-coated tablet when dosed fasted following rabeprazole pretreatment
Measured: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Secondary outcomes (9)
Number of participants with treatment-emergent adverse events (AEs)
To evaluate the safety and tolerability of PF 07799933 and PF-07799544 when co-administered in healthy adult participants including a new formulation of PF 07799933 and following a high-fat meal. AEs as characterized by type, frequency, severity, and relationship to study intervention.
Measured: From Baseline up to Day 35
Number of participants with treatment-emergent laboratory abnormalities.
To evaluate the safety and tolerability of PF 07799933 and PF-07799544 when co-administered in healthy adult participants including a new formulation of PF 07799933 and following a high-fat meal. Laboratory abnormalities as characterized by type, frequency, severity, and relationship to study intervention.
Measured: From Baseline up to Day 35
Number of participants with treatment-emergent vital sign abnormalities.
To evaluate the safety and tolerability of PF 07799933 and PF-07799544 when co-administered in healthy adult participants including a new formulation of PF 07799933 and following a high-fat meal. Vital sign abnormalities as characterized by type, frequency, severity, and relationship to study intervention.
Measured: From Baseline up to Day 35
Number of participants with treatment-emergent electrocardiogram (ECG) abnormalities.
To evaluate the safety and tolerability of PF 07799933 and PF-07799544 when co-administered in healthy adult participants including a new formulation of PF 07799933 and following a high-fat meal. ECG abnormalities as characterized by type, frequency, severity, and relationship to study intervention.
Measured: From Baseline up to Day 35
Number of participants with treatment-emergent physical exam abnormalities.
To evaluate the safety and tolerability of PF 07799933 and PF-07799544 when co-administered in healthy adult participants including a new formulation of PF 07799933 and following a high-fat meal. Physical exam abnormalities as characterized by type, frequency, severity, and relationship to study intervention.
Measured: From Baseline up to Day 35
To evaluate the safety and tolerability of PF-07799933 when coadministered with and without rabeprazole in healthy adult participants: Number of participants with treatment-emergent AEs.
AEs characterized by type, frequency, severity, and relationship to study intervention.
Measured: From Baseline up to Day 35
To evaluate the safety and tolerability of PF-07799933 when coadministered with and without rabeprazole in healthy adult participants: Number of participants with treatment-emergent laboratory abnormalities.
Laboratory abnormalities as characterized by type, frequency, severity, and relationship to study intervention.
Measured: From Baseline up to Day 35
To evaluate the safety and tolerability of PF-07799933 when coadministered with and without rabeprazole in healthy adult participants: Number of participants with treatment-emergent ECG abnormalities.
ECG abnormalities as characterized by type, frequency, severity, and relationship to study intervention.
Measured: From Baseline up to Day 35
To evaluate the safety and tolerability of PF-07799933 when coadministered with and without rabeprazole in healthy adult participants: Number of participants with physical exam abnormalities.
Physical exam abnormalities as characterized by type, frequency, severity, and relationship to study intervention.
Measured: From Baseline up to Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start10 Apr 2026
- Primary completion24 Jun 2026
- Study completion26 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563894
- Sponsor's protocol ID
- C4901006
- Status last verified
- Jul 2026
- First submitted
- 6 Apr 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-Label, Single-Dose, Two Cohort Crossover Study to Evaluate the Relative Bioavailability of a Test Formulation of PF-07799933 and the Effect of a High-Fat Meal on Plasma Pharmacokinetics of PF-07799933 and PF 07799544 Administered in Combination, and the Impact of a Proton Pump Inhibitor on the Plasma Pharmacokinetics of PF-07799933, in Healthy Participants.
- ClinicalTrials.gov ID
- NCT07563894
- Acronym / sponsor ID
- C4901006
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 24 Jun 2026 (actual)
- Study completion
- 26 Jun 2026 (actual)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the relative bioavailability (rBA) of the Form 2 film-coated tablet of PF-07799933 intended for use in future studies compared to the current Form 1 tablet of PF-07799933 used in Phase 1 studies. Additionally this study will also evaluate the effect of a high-fat meal on the plasma pharmacokinetics (PK), i.e, the rBA compared to overnight fasting, of PF-07799933 and PF-07799544 following concurrent single-dose oral administration of Form 2 film-coated tablet formulation of PF-07799933 with PF-07799544. Finally, this study will also assess the impact of a proton pump inhibitor (a type of acid reducing agent) on PF-07799933 PK of the Form 2 film-coated tablet formulation. These data will be used to inform administration of PF-07799933 and PF-07799544 with food and acid reducing agents in future clinical trials.
Detailed description
This is a Phase 1, open-label, randomized, single-dose, 2-cohort study: a three period two sequence crossover (Relative Bioavailability and Food Effect) cohort in healthy adult participants, and a two-period single sequence cohort (Proton Pump Inhibitor) in healthy adult participants. Cohort 1 of this study, which has 3 periods, will evaluate the impact of the Form 2 film-coated tablet of PF-07799933 (test formulation) compared to the Form 1 tablet of PF-07799933 (reference formulation) used in the C4901001 and C4761001 Phase 1 studies (Period 1 and Period 2). This cohort (Cohort 1) will also evaluate the effect of a high fat meal on plasma pharmacokinetics (ie, the relative bioavailability compared to overnight fasting) of the Form 2 film-coated tablet of PF-07799933 and of PF-07799544 following concurrent single-dose administrations of 300 mg of PF 07799933 and the optimized dose identified from an ongoing clinical study (either 7.5 or 12 mg) of PF 07799544 to healthy adult participants (Period 3). Cohort 2, which has two periods, will evaluate the plasma pharmacokinetics of PF-07799933 before (Period 1) and after administration of the proton pump inhibitor rabeprazole (20 mg BID for 3 days and once in the morning for the last dose [seven total doses]) (Period 2). Cohort 2 will be conducted using the Form 2 film-coated tablet of PF-07799933 in both periods.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PF-07799933 Form 1 Tablet Arm with PF-07799544 Fasted | Experimental | Drug: PF-07799933 tablets with PF-07799544 fastedCohort 1 Period 1: Participants receive PF-07799933 tablets in Combination With PF-07799544 |
| PF-07799933 Form 2 Film-Coated Tablet Arm with PF-07799544 Fasted | Experimental | Drug: PF-07799933 film-coated tablets with PF-07799544 fastedCohort 1 Period 2: Participants receive PF-07799933 film-coated tablets in Combination With PF-07799544 |
| PF-07799933 Form 2 Film-Coated Tablet Arm with PF-07799544 under Fed Conditions | Experimental | Drug: PF-07799933 film-coated tablets with PF-07799544 fedCohort 1 Period 3: Participants receive PF-07799933 film-coated tablets in Combination With PF-07799544 following a High-Fat Meal |
| PF-07799933 Form 2 Tablet Arm | Experimental | Drug: PF-07799933 film-coated tablets fastedCohort 2 Period 1: Participants receive PF-07799933 film-coated tablets |
| PF-07799933 Form 2 Tablet Arm following Rabeprazole Pretreatment | Experimental | Drug: PF-07799933 film-coated tablets following rabeprazole pretreatment fastedCohort 2 Period 1: Participants receive PF-07799933 film-coated tablets following rabeprazole treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female participants of non-childbearing potential and male participants 18 to 65 years of age (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and ECGs.
- BMI of 16-32 kg/m2; and a total body weight >50 kg (110 lb)
Key exclusion criteria (21 listed)
- Evidence or history of clinically significant uveitis, 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, chronic diarrhea, - inflammatory bowel disease).
- History of HIV infection, hepatitis B, or hepatitis C
- History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (eg,glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes); history of retinal degenerative disease (including evidence of macular degeneration); blurred vision.
- Any evidence of active bacterial, fungal, or viral infection
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-07799933 tablets with PF-07799544 fastedParticipants receive Form 1 in a single dose of tablet in a single dose combination fasted | Drug | PF-07799933 Form 1 Tablet Arm with PF-07799544 Fasted |
| PF-07799933 film-coated tablets with PF-07799544 fastedParticipants receive Form 2 in a single dose of tablet in a single dose combination fasted | Drug | PF-07799933 Form 2 Film-Coated Tablet Arm with PF-07799544 Fasted |
| PF-07799933 film-coated tablets with PF-07799544 fedParticipants receive Form 2 in a single dose of tablet in a single dose combination in the fed state | Drug | PF-07799933 Form 2 Film-Coated Tablet Arm with PF-07799544 under Fed Conditions |
| PF-07799933 film-coated tablets fastedParticipants receive Form 2 in a single dose of tablet fasted | Drug | PF-07799933 Form 2 Tablet Arm |
| PF-07799933 film-coated tablets following rabeprazole pretreatment fastedParticipants receive Form 2 in a single dose of tablet following rabeprazole pre-treatment fasted | Drug | PF-07799933 Form 2 Tablet Arm following Rabeprazole Pretreatment |
Primary outcome
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-07799933 Form 1 tablet when dosed in combination with PF-07799544 fasted
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-07799933 Form 2 film-coated tablet when dosed in combination with PF-07799544 fasted
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to The Last Measured Time Point (AUClast) for PF-07799933 Form 1 tablet when dosed in combination with PF-07799544 fasted
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to The Last Measured Time Point (AUClast) for PF-07799933 Form 2 film-coated tablet when dosed in combination with PF-07799544 fasted
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Maximum Observed Plasma Concentration (Cmax) for PF-07799933 Form 1 tablet when dosed in combination with PF-07799544 fasted
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Maximum Observed Plasma Concentration (Cmax) for PF-07799933 Form 2 film-coated tablet when dosed in combination with PF-07799544 fasted
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-07799933 Form 2 film-coated tablet when dosed in combination with PF-07799544 under fed conditions
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to The Last Measured Time Point (AUClast) for PF-07799933 Form 2 film-coated tablet when dosed in combination with PF-07799544 under fed conditions
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Maximum Observed Plasma Concentration (Cmax) for PF-07799933 Form 2 film-coated tablet when dosed in combination with PF-07799544 under fed conditions
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-07799544 tablet when dosed in combination with Form 2 film-coated tablet of PF-07799933 fasted
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to The Last Measured Time Point (AUClast) for PF-07799544 tablet when dosed in combination with Form 2 film-coated tablet of PF-07799933 fasted
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Maximum Observed Plasma Concentration (Cmax) for PF-07799544 tablet when dosed in combination with Form 2 film-coated tablet of PF-07799933 fasted
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-07799544 tablet when dosed in combination with Form 1 tablet of PF-07799933 fasted
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to The Last Measured Time Point (AUClast) for PF-07799544 tablet when dosed in combination with Form 1 tablet of PF-07799933 fasted
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Maximum Observed Plasma Concentration (Cmax) for PF-07799544 tablet when dosed in combination with Form 1 tablet of PF-07799933 fasted
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-07799544 tablet when dosed in combination with Form 2 film-coated tablet of PF-07799933 under fed conditions
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to The Last Measured Time Point (AUClast) for PF-07799544 tablet when dosed in combination with Form 2 film-coated tablet of PF-07799933 under fed conditions
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Maximum Observed Plasma Concentration (Cmax) for PF-07799544 tablet when dosed in combination with Form 2 film-coated tablet of PF-07799933 under fed conditions
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-07799933 Form 2 film-coated tablet when dosed fasted
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to The Last Measured Time Point (AUClast) for PF-07799933 Form 2 film-coated tablet when dosed fasted
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Maximum Observed Plasma Concentration (Cmax) for PF-07799933 Form 2 film-coated tablet when dosed fasted
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-07799933 Form 2 film-coated tablet when dosed fasted following rabeprazole pretreatment
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Area Under the Curve From Time Zero to The Last Measured Time Point (AUClast) for PF-07799933 Form 2 film-coated tablet when dosed fasted following rabeprazole pretreatment
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
Maximum Observed Plasma Concentration (Cmax) for PF-07799933 Form 2 film-coated tablet when dosed fasted following rabeprazole pretreatment
Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose
9 secondary outcomes
Number of participants with treatment-emergent adverse events (AEs)
Time frame: From Baseline up to Day 35
Number of participants with treatment-emergent laboratory abnormalities.
Time frame: From Baseline up to Day 35
Number of participants with treatment-emergent vital sign abnormalities.
Time frame: From Baseline up to Day 35
Number of participants with treatment-emergent electrocardiogram (ECG) abnormalities.
Time frame: From Baseline up to Day 35
Number of participants with treatment-emergent physical exam abnormalities.
Time frame: From Baseline up to Day 35
To evaluate the safety and tolerability of PF-07799933 when coadministered with and without rabeprazole in healthy adult participants: Number of participants with treatment-emergent AEs.
Time frame: From Baseline up to Day 35
To evaluate the safety and tolerability of PF-07799933 when coadministered with and without rabeprazole in healthy adult participants: Number of participants with treatment-emergent laboratory abnormalities.
Time frame: From Baseline up to Day 35
To evaluate the safety and tolerability of PF-07799933 when coadministered with and without rabeprazole in healthy adult participants: Number of participants with treatment-emergent ECG abnormalities.
Time frame: From Baseline up to Day 35
To evaluate the safety and tolerability of PF-07799933 when coadministered with and without rabeprazole in healthy adult participants: Number of participants with physical exam abnormalities.
Time frame: From Baseline up to Day 35
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- 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-07799933 tablets with PF-07799544 fasted, PF-07799933 film-coated tablets with PF-07799544 fasted and PF-07799933 film-coated tablets with PF-07799544 fed in people with Healthy, 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 2 inclusion and 21 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 9 Jul 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-07799933 Form 1 tablet when dosed in combination with PF-07799544 fasted (time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2026.