Healthy AdultsPhase 1NCT07514156
A Study to Learn How Different Amounts of the Study Medicine Called PF-07940369 Are Tolerated and Act in the Body in Healthy Adults.
A Phase 1 study testing PF-07940369 in people with Healthy Adults, run by Pfizer at 1 site in Belgium.
Trial summary
The purpose of this study is to learn about the safety and tolerability of a study medicine called PF-07940369 when it is taken by mouth in different amounts and/or at multiples times a day by healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- PF-07940369
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Jul 2025to 6 Jan 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
- Male participants and female participants who are not of childbearing potential who are overtly healthy as determine by medical evaluation including medical history, physical examination, laboratory tests, and standard 12 lead electrocardiogram (ECG).
- Body mass index (BMI) of 16 to 32 kg/m2; and a total body weight >50 kg (110 lb).
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
- Any of the following conditions: History of iron storage diseases, History of iron utilization disorder, Diagnosis of hemolytic anemia or hemoglobinopathy, Diagnosis of iron deficiency anemia, Recent blood donation.
- History of intravenous iron therapy, erythropoiesis stimulating agent therapy and/or oral iron containing concomitant medications or nutritional supplements exceeding recommended dietary allowances for iron in adults.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, B-1070
About this study
Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO CONTROLLED, MULTIPLE ASCENDING DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF 07940369 IN HEALTHY ADULT PARTICIPANTS
The purpose of this study is to learn about the safety and tolerability of a study medicine called PF-07940369 when it is taken by mouth in different amounts and/or at multiples times a day by healthy adult participants. The study will also look at the pharmacokinetics of PF-07940369 (how the medicine is changed and eliminated from the body).
The study is seeking participants that are:
Read more
- male or female aged between 18 to 65 years
- have a body mass index (BMI) of 16 to 32 kilogram per meter squared, and
- are considered to be generally healthy by the study doctor.
In each dose group, 10 participants will be randomly assigned to take PF-07940369 (8 participants) or placebo (2 participants). A placebo does not have any medicine in it but looks just like the medicine being studied. Participants will receive the study medication by mouth 1 to 2 times a day for 14 days while admitted to the study clinic.
The study team will look for the experiences of people receiving the study medicine. This will help the team see if the study medicine is safe and if the study can go to the next dose group. An optional Japanese group may be conducted later.
Participants will take part in this study for 10 weeks. During this time, the participants will stay in the study clinic for 16 days to receive the study medication. The participants will have multiple blood samples drawn during dosing for safety laboratory assessments and up to 48 hours after receiving the last dose of PF-07940369 to look at how the body processes the study medicine. After being discharged from the study clinic, the participants will have a study visit 7 to 10 days after the last dose. The study team will also call participants one time over the phone 28 to 35 days after receiving their last dose on Day 14.
- Conditions
- Healthy Adults
- Being tested
- PF-07940369, Placebo
- Keywords
- Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-07940369Drug
Oral Tablets
PlaceboDrug
Oral Tablets
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1, PF-07940369 or Placebo | Experimental | Multiple oral dosing Receives: Drug: PF-07940369; Drug: Placebo |
| Cohort 2, PF-07940369 or Placebo | Experimental | Multiple oral dosing Receives: Drug: PF-07940369; Drug: Placebo |
| Cohort 3, PF-07940369 or Placebo | Experimental | Multiple oral dosing Receives: Drug: PF-07940369; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (AEs)
Measured: Baseline (Day 0) up to 35 days after last dose of study drug
Secondary outcomes (4)
Maximum Observed Plasma Concentration (Cmax) of PF-07940369
Measured: Pre-dose (0), 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07940369
Measured: Pre-dose (0), 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-07940369
Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval is 12 or 24 hours.
Measured: Pre-dose (0), 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose
Percent of Dose Recovered in Urine as Unchanged Drug (Aetau%)
PF-07940369 urinary PK parameters: Aetau%
Measured: 0 to 12 hours or 0 to 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start15 Jul 2025
- Primary completion6 Jan 2026
- Study completion6 Jan 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
- Parallel groups
- Model description
- Randomized, double-blind (investigator- and participant-blinded), sponsor-open, placebo-controlled, multiple ascending oral dose escalation
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 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
- NCT07514156
- Sponsor's protocol ID
- C5381002
- Other IDs
- 2025-520558-12-00, 2025
- Status last verified
- Apr 2026
- First submitted
- 3 Jul 2025
- Last updated
- 7 Apr 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 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO CONTROLLED, MULTIPLE ASCENDING DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF 07940369 IN HEALTHY ADULT PARTICIPANTS
- ClinicalTrials.gov ID
- NCT07514156
- Acronym / sponsor ID
- C5381002
- Conditions
- Healthy Adults
- Keywords
- Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 6 Jan 2026 (actual)
- Study completion
- 6 Jan 2026 (actual)
- First posted
- 7 Apr 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 about the safety and tolerability of a study medicine called PF-07940369 when it is taken by mouth in different amounts and/or at multiples times a day by healthy adult participants. The study will also look at the pharmacokinetics of PF-07940369 (how the medicine is changed and eliminated from the body).
The study is seeking participants that are:
- male or female aged between 18 to 65 years
- have a body mass index (BMI) of 16 to 32 kilogram per meter squared, and
- are considered to be generally healthy by the study doctor.
In each dose group, 10 participants will be randomly assigned to take PF-07940369 (8 participants) or placebo (2 participants). A placebo does not have any medicine in it but looks just like the medicine being studied. Participants will receive the study medication by mouth 1 to 2 times a day for 14 days while admitted to the study clinic.
The study team will look for the experiences of people receiving the study medicine. This will help the team see if the study medicine is safe and if the study can go to the next dose group. An optional Japanese group may be conducted later.
Participants will take part in this study for 10 weeks. During this time, the participants will stay in the study clinic for 16 days to receive the study medication. The participants will have multiple blood samples drawn during dosing for safety laboratory assessments and up to 48 hours after receiving the last dose of PF-07940369 to look at how the body processes the study medicine. After being discharged from the study clinic, the participants will have a study visit 7 to 10 days after the last dose. The study team will also call participants one time over the phone 28 to 35 days after receiving their last dose on Day 14.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Randomized, double-blind (investigator- and participant-blinded), sponsor-open, placebo-controlled, multiple ascending oral dose escalation
| Arm | Type | Receives |
|---|---|---|
| Cohort 1, PF-07940369 or Placebo | Experimental | Drug: PF-07940369, Drug: PlaceboMultiple oral dosing |
| Cohort 2, PF-07940369 or Placebo | Experimental | Drug: PF-07940369, Drug: PlaceboMultiple oral dosing |
| Cohort 3, PF-07940369 or Placebo | Experimental | Drug: PF-07940369, Drug: PlaceboMultiple oral dosing |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male participants and female participants who are not of childbearing potential who are overtly healthy as determine by medical evaluation including medical history, physical examination, laboratory tests, and standard 12 lead electrocardiogram (ECG).
- Body mass index (BMI) of 16 to 32 kg/m2; and a total body weight >50 kg (110 lb).
Key exclusion criteria (3 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
- Any of the following conditions: History of iron storage diseases, History of iron utilization disorder, Diagnosis of hemolytic anemia or hemoglobinopathy, Diagnosis of iron deficiency anemia, Recent blood donation.
- History of intravenous iron therapy, erythropoiesis stimulating agent therapy and/or oral iron containing concomitant medications or nutritional supplements exceeding recommended dietary allowances for iron in adults.
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-07940369Oral Tablets | Drug | Cohort 1, PF-07940369 or Placebo, Cohort 2, PF-07940369 or Placebo, Cohort 3, PF-07940369 or Placebo |
| PlaceboOral Tablets | Drug | Cohort 1, PF-07940369 or Placebo, Cohort 2, PF-07940369 or Placebo, Cohort 3, PF-07940369 or Placebo |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (AEs)
Time frame: Baseline (Day 0) up to 35 days after last dose of study drug
4 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) of PF-07940369
Time frame: Pre-dose (0), 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07940369
Time frame: Pre-dose (0), 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-07940369
Time frame: Pre-dose (0), 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose
Percent of Dose Recovered in Urine as Unchanged Drug (Aetau%)
Time frame: 0 to 12 hours or 0 to 24 hours post-dose
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 7 Apr 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-07940369 in people with Healthy Adults, 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 2 inclusion and 3 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 7 Apr 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 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?
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?
Number of Participants With Treatment Emergent Adverse Events (AEs) (time frame: Baseline (Day 0) up to 35 days after last dose of study drug). 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 7 Apr 2026.