Healthy VolunteersPhase 1NCT06670170
A Study to Learn How Different Forms of the Study Medicine Called PF-07976016 Are Taken Up Into the Blood in Healthy Adults
A Phase 1 study testing PF-07976016 Formulation A and PF-07976016 Formulation B in people with Healthy Volunteers, run by Pfizer at 1 site in United States.
Trial summary
The primary purpose of this study is to measure and compare the amount of study drug in your blood after a single dose of two formulations of study drug. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- PF-07976016 Formulation A and PF-07976016 Formulation B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2024to 17 Jan 2025
- 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
- Overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and ECG assessments.
- Willing to provide consent and follow study requirements
- Total body weight >110lbs (50kg)
Who cannot join
- Any condition affecting drug absorption, clinically significant laboratory values
- HIV, HepB \& HepC
- Serious illness or hospitalization, or other condition, 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 non-prescription drugs within a specified timeframe prior to the first dose of study intervention
- positive urine drug test at screening/admission
- History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of screening
- Use of tobacco/nicotine containing products more than the equivalent of 5 cigarettes/day or 2 chews of tobacco/day
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 CROSSOVER STUDY TO COMPARE THE SINGLE-DOSE PHARMACOKINETICS OF TWO FORMULATIONS OF PF-07976016 ADMINISTERED ORALLY TO HEALTHY ADULT PARTICIPANTS
The primary purpose of this study is to measure and compare the amount of study drug in your blood after a single dose of two formulations of study drug.
- Conditions
- Healthy Volunteers
- Being tested
- PF-07976016 Formulation A, PF-07976016 Formulation B
- Keywords
- Healthy Participants, Healthy Subjects, Human Volunteers, Normal Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-07976016 Formulation ADrug
PF-07976016; formulation A - current/reference
PF-07976016 Formulation BDrug
PF-07976016; Formulation B - new/test
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Participants will receive a single dose of PF-07976016 in up to 3 study periods. In sequence 1, participants will receive formulation A followed by formulation B. There will be 7 days between each dose as a wash out period. Receives: Drug: PF-07976016 Formulation A; Drug: PF-07976016 Formulation B |
| Sequence 2 | Experimental | Participants will receive single doses of PF-07976016 in up to 3 study periods. In sequence 2, participants will receive formulation B followed by formulation A. There will be 7 days between each dose as a wash out period. Receives: Drug: PF-07976016 Formulation A; Drug: PF-07976016 Formulation B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve - infinity - AUCinf (as data permit, otherwise AUClast).
Measured: Day 1 Hour 0 (pre-dose) through 168 hours post dose in each period
Secondary outcomes (1)
Incidence of Treatment Emergent Adverse Events - TEAEs
Measured: From first dose (Day 1) up to 28-35 days after final dose; a total of approximately 51 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start5 Nov 2024
- Primary completion24 Dec 2024
- Study completion17 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
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
- NCT06670170
- Sponsor's protocol ID
- C5541005
- Other IDs
- NCT06670170
- Status last verified
- Sep 2025
- First submitted
- 31 Oct 2024
- Last updated
- 22 Sep 2025
- 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 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN-LABEL, RANDOMIZED CROSSOVER STUDY TO COMPARE THE SINGLE-DOSE PHARMACOKINETICS OF TWO FORMULATIONS OF PF-07976016 ADMINISTERED ORALLY TO HEALTHY ADULT PARTICIPANTS
- ClinicalTrials.gov ID
- NCT06670170
- Acronym / sponsor ID
- C5541005
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Participants, Healthy Subjects, Human Volunteers, Normal Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 24 Dec 2024 (actual)
- Study completion
- 17 Jan 2025 (actual)
- First posted
- 1 Nov 2024 (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 primary purpose of this study is to measure and compare the amount of study drug in your blood after a single dose of two formulations of study drug.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: PF-07976016 Formulation A, Drug: PF-07976016 Formulation BParticipants will receive a single dose of PF-07976016 in up to 3 study periods. In sequence 1, participants will receive formulation A followed by formulation B. There will be 7 days between each dose as a wash out period. |
| Sequence 2 | Experimental | Drug: PF-07976016 Formulation A, Drug: PF-07976016 Formulation BParticipants will receive single doses of PF-07976016 in up to 3 study periods. In sequence 2, participants will receive formulation B followed by formulation A. There will be 7 days between each dose as a wash out period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and ECG assessments.
- Willing to provide consent and follow study requirements
- Total body weight >110lbs (50kg)
Key exclusion criteria (7 listed)
- Any condition affecting drug absorption, clinically significant laboratory values
- HIV, HepB \& HepC
- Serious illness or hospitalization, or other condition, 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 non-prescription drugs within a specified timeframe prior to the first dose of study intervention
- positive urine drug test at screening/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 |
|---|---|---|
| PF-07976016 Formulation APF-07976016; formulation A - current/reference | Drug | Sequence 1, Sequence 2 |
| PF-07976016 Formulation BPF-07976016; Formulation B - new/test | Drug | Sequence 1, Sequence 2 |
Primary outcome
Area Under the Curve - infinity - AUCinf (as data permit, otherwise AUClast).
Time frame: Day 1 Hour 0 (pre-dose) through 168 hours post dose in each period
1 secondary outcome
Incidence of Treatment Emergent Adverse Events - TEAEs
Time frame: From first dose (Day 1) up to 28-35 days after final dose; a total of approximately 51 days
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 22 Sep 2025.
- 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-07976016 Formulation A and PF-07976016 Formulation B in people with Healthy Volunteers, 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 7 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 22 Sep 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 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 - infinity - AUCinf (as data permit, otherwise AUClast). (time frame: Day 1 Hour 0 (pre-dose) through 168 hours post dose in each period). 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 22 Sep 2025.