Healthy AdultsPhase 1NCT07597928
A Study to Learn How Different Forms of the Study Medicine Called PF-08049820 Are Absorbed and Eliminated in Healthy Adults
A Phase 1 study testing PF-08049820 and Rabeprazole in people with Healthy Adults and Healthy, run by Pfizer at 1 site in United States.
Trial summary
The purpose of this study is to learn how different forms of the study medicine called PF-08049820 are absorbed and eliminated in healthy adults. The study will assess whether the study medicine is absorbed differently when taken with or without food. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults, Healthy
- What is being tested?
- PF-08049820 and Rabeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2026to 1 Sep 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males and females.
- At least 18 years of age
- Body mass index (BMI) of 16-32 kg/m2; and a total body weight >50kg (110 lb.).
Who cannot join
- Evidence or history of clinically significant medical conditions.
- History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B or hepatitis C.
- History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
- Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
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, RANDOMIZED, 5-PERIOD, 6-SEQUENCE, CROSSOVER STUDY TO COMPARE THE SINGLE-DOSE PHARMACOKINETICS OF ONE IMMEDIATE RELEASE AND TWO MODIFIED-RELEASE FORMULATIONS OF PF-08049820 ADMINISTERED ORALLY UNDER FASTED AND FED CONDITIONS (PART A), AND A FIXED SEQUENCE STUDY TO ASSESS THE EFFECT OF RABEPRAZOLE ON THE PHARMACOKINETICS OF PF-08049820 (PART B), IN HEALTHY ADULTS
The purpose of this study is to learn how different forms of the study medicine called PF-08049820 are absorbed and eliminated in healthy adults. The study will assess whether the study medicine is absorbed differently when taken with or without food. It will also assess absorption when the study medicine is taken with another medicine called rabeprazole. Rabeprazole is an FDA approved medicine that reduces stomach acid.
The study has two parts. In Part A, participants will take three forms of study medicine, one after the other. They will take each form either with or without food for a total of five doses. Each dose will be separated by a few days. Participants will stay in the clinic for about two weeks. They will receive a telephone follow-up call about a month after the last dose.
Read more
In Part B, participants will take three forms of study medicine. They will take each one with or without food, and with or without another medicine called rabeprazole. This means they will take a total of six doses of study medicine. Each dose will be separated by a few days. Participants will stay at the clinic for about three weeks, and about a month after their last dose. They will get a follow-up phone call. Part B may or may not be conducted depending on the results from Part A.
The study is seeking participants who:
- Are males or females,
- Are at least 18 years of age,
- Have a body mass index (BMI) 16 to 32 kilograms per meter squared (kg/m2). Have a total body weight of more than 50 kilograms (kg) (110 pounds).
- Conditions
- Healthy Adults, Healthy
- Being tested
- PF-08049820, Rabeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-08049820Drug
Administered orally
RabeprazoleDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Sequence 5 (Part A) | Experimental | 3 different formulations of PF-08049820 administered orally under fasted or fed conditions. Receives: Drug: PF-08049820 |
| Sequence 7 (Optional Part B) | Experimental | 3 different formulations of PF-08049820 administered orally with or without rabeprazole under fasted or fed conditions. Receives: Drug: PF-08049820; Drug: Rabeprazole |
| Sequence 1 (Part A) | Experimental | 3 different formulations of PF-08049820 administered orally under fasted or fed conditions. Receives: Drug: PF-08049820 |
| Sequence 2 (Part A) | Experimental | 3 different formulations of PF-08049820 administered orally under fasted or fed conditions. Receives: Drug: PF-08049820 |
| Sequence 3 (Part A) | Experimental | 3 different formulations of PF-08049820 administered orally under fasted or fed conditions. Receives: Drug: PF-08049820 |
| Sequence 4 (Part A) | Experimental | 3 different formulations of PF-08049820 administered orally under fasted or fed conditions. Receives: Drug: PF-08049820 |
| Sequence 6 (Part A) | Experimental | 3 different formulations of PF-08049820 administered orally under fasted or fed conditions. Receives: Drug: PF-08049820 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Part A: Evaluate the relative bioavailability of different formulations of PF-08049820.
Optional Part B: Estimate the effect of rabeprazole on the PK of different formulations of PF-08049820.
Measured: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit
Part A: Evaluate the relative bioavailability of 3 different formulations of PF-08049820.
Optional Part B: Estimate the effect of rabeprazole on the PK of different formulations of PF-08049820.
Measured: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
Maximum observed plasma concentration (Cmax)
Part A: Evaluate the relative bioavailability of 3 different formulations of PF-08049820.
Optional Part B: Estimate the effect of rabeprazole on the PK of different formulations of PF-08049820.
Measured: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
Secondary outcomes (8)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Part A and optional Part B
Measured: Baseline up to Day 48 for Part A and up to Day 56 for optional Part B
Number of Participants With Serious Adverse Events (SAEs)
Part A and optional Part B
Measured: Baseline up to Day 48 for Part A and up to Day 56 for optional Part B
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Part A and optional Part B
Measured: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Part A and optional Part B
Measured: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
Part A and optional Part B
Measured: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Part A only: Evaluate the food effect on the PK of different formulations of PF-08049820.
Measured: Baseline up to Day 16 for Part A
Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit
Part A only: Evaluate the food effect on the PK of different formulations of PF-08049820.
Measured: Baseline up to Day 16 for Part A
Maximum observed plasma concentration (Cmax)
Part A only: Evaluate the food effect on the PK of different formulations of PF-08049820.
Measured: Baseline up to Day 16 for Part A
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start13 May 2026
- Primary completion7 Aug 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies 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
- 24 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
- NCT07597928
- Sponsor's protocol ID
- C6231008
- Status last verified
- Sep 2026
- First submitted
- 12 May 2026
- Last updated
- 1 Oct 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 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN-LABEL, RANDOMIZED, 5-PERIOD, 6-SEQUENCE, CROSSOVER STUDY TO COMPARE THE SINGLE-DOSE PHARMACOKINETICS OF ONE IMMEDIATE RELEASE AND TWO MODIFIED-RELEASE FORMULATIONS OF PF-08049820 ADMINISTERED ORALLY UNDER FASTED AND FED CONDITIONS (PART A), AND A FIXED SEQUENCE STUDY TO ASSESS THE EFFECT OF RABEPRAZOLE ON THE PHARMACOKINETICS OF PF-08049820 (PART B), IN HEALTHY ADULTS
- ClinicalTrials.gov ID
- NCT07597928
- Acronym / sponsor ID
- C6231008
- Conditions
- Healthy Adults, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 13 May 2026 (actual)
- Primary completion
- 7 Aug 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 20 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 learn how different forms of the study medicine called PF-08049820 are absorbed and eliminated in healthy adults. The study will assess whether the study medicine is absorbed differently when taken with or without food. It will also assess absorption when the study medicine is taken with another medicine called rabeprazole. Rabeprazole is an FDA approved medicine that reduces stomach acid.
The study has two parts. In Part A, participants will take three forms of study medicine, one after the other. They will take each form either with or without food for a total of five doses. Each dose will be separated by a few days. Participants will stay in the clinic for about two weeks. They will receive a telephone follow-up call about a month after the last dose.
In Part B, participants will take three forms of study medicine. They will take each one with or without food, and with or without another medicine called rabeprazole. This means they will take a total of six doses of study medicine. Each dose will be separated by a few days. Participants will stay at the clinic for about three weeks, and about a month after their last dose. They will get a follow-up phone call. Part B may or may not be conducted depending on the results from Part A.
The study is seeking participants who:
- Are males or females,
- Are at least 18 years of age,
- Have a body mass index (BMI) 16 to 32 kilograms per meter squared (kg/m2). Have a total body weight of more than 50 kilograms (kg) (110 pounds).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Sequence 5 (Part A) | Experimental | Drug: PF-080498203 different formulations of PF-08049820 administered orally under fasted or fed conditions. |
| Sequence 7 (Optional Part B) | Experimental | Drug: PF-08049820, Drug: Rabeprazole3 different formulations of PF-08049820 administered orally with or without rabeprazole under fasted or fed conditions. |
| Sequence 1 (Part A) | Experimental | Drug: PF-080498203 different formulations of PF-08049820 administered orally under fasted or fed conditions. |
| Sequence 2 (Part A) | Experimental | Drug: PF-080498203 different formulations of PF-08049820 administered orally under fasted or fed conditions. |
| Sequence 3 (Part A) | Experimental | Drug: PF-080498203 different formulations of PF-08049820 administered orally under fasted or fed conditions. |
| Sequence 4 (Part A) | Experimental | Drug: PF-080498203 different formulations of PF-08049820 administered orally under fasted or fed conditions. |
| Sequence 6 (Part A) | Experimental | Drug: PF-080498203 different formulations of PF-08049820 administered orally under fasted or fed conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy males and females.
- At least 18 years of age
- Body mass index (BMI) of 16-32 kg/m2; and a total body weight >50kg (110 lb.).
Key exclusion criteria (4 listed)
- Evidence or history of clinically significant medical conditions.
- History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B or hepatitis C.
- History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
- Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
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-08049820Administered orally | Drug | Sequence 1 (Part A), Sequence 2 (Part A), Sequence 3 (Part A), Sequence 4 (Part A), Sequence 5 (Part A), Sequence 6 (Part A), Sequence 7 (Optional Part B) |
| RabeprazoleAdministered orally | Drug | Sequence 7 (Optional Part B) |
Primary outcome
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Time frame: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
Part A: Evaluate the relative bioavailability of different formulations of PF-08049820. Optional Part B: Estimate the effect of rabeprazole on the PK of different formulations of PF-08049820.
Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit
Time frame: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
Part A: Evaluate the relative bioavailability of 3 different formulations of PF-08049820. Optional Part B: Estimate the effect of rabeprazole on the PK of different formulations of PF-08049820.
Maximum observed plasma concentration (Cmax)
Time frame: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
Part A: Evaluate the relative bioavailability of 3 different formulations of PF-08049820. Optional Part B: Estimate the effect of rabeprazole on the PK of different formulations of PF-08049820.
8 secondary outcomes
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline up to Day 48 for Part A and up to Day 56 for optional Part B
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Baseline up to Day 48 for Part A and up to Day 56 for optional Part B
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Time frame: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
Time frame: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Time frame: Baseline up to Day 16 for Part A
Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit
Time frame: Baseline up to Day 16 for Part A
Maximum observed plasma concentration (Cmax)
Time frame: Baseline up to Day 16 for Part A
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 1 Oct 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-08049820 and Rabeprazole in people with Healthy Adults and 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 3 inclusion and 4 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 1 Oct 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 concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) (time frame: Baseline up to Day 16 for Part A and up to Day 24 for optional Part B). The study lists 3 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 1 Oct 2026.