HealthyPhase 1NCT06532383
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, run by Pfizer at 1 site in Belgium.
Trial summary
The purpose of the study is to evaluate the safety, tolerability, and Pharmacokinetics (Pharmacokinetics [PK] to better understand how the drug is changed and eliminated from your body after you take it) of single ascending oral doses of PF-07940369 in 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
- 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
- 22 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Aug 2024to 16 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants are eligible to be included in the study only if all of the following criteria apply:
- -Male participants and female participants who are not of childbearing potential who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, blood pressure, pulse rate and standard 12 lead ECG.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Any of the following conditions: History of iron storage diseases such as hemochromatosis. History of iron utilization disorder such as sideroblastic anemia. Diagnosis of hemolytic anemia or hemoglobinopathy (eg thalassemia). Diagnosis of iron deficiency anemia within 3 months prior to screening. Recent blood donation (within 60 days prior to first dose).
- History of intravenous iron therapy, erythropoiesis stimulating agent therapy (eg erythropoietin) and/or oral iron containing concomitant medications or nutritional supplements exceeding recommended dietary allowances for iron in adults (adult men age 19-50 years: 8 mg, adult women 19-50 years: 18 mg, adults >50 years: 8 mg on weekly average in the 4 weeks prior to randomization).
- 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 <90 mL/min/1.73m², as determined by the CKD-EPI equation using Screat calculated using the recommended formulas
- Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF >450 ms, complete LBBB, signs of an acute or indeterminate- age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second- or third- degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If QTcF exceeds 450 ms, or QRS exceeds 120 ms, the ECG should be repeated twice and the average of the 3 QTcF or QRS values used to determine the participant's eligibility. Computer-interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding a participant.
- Participants with ANY of the following abnormalities in clinical laboratory tests at screening and prior to dosing in each period, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary: ALT, AST, Bilirubin ≥1.05 x ULN. Participants with an elevated total bilirubin consistent with Gilberts Disease may have a direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN. Hb <LLN. Serum ferritin < lower limit of the reference range or > upper limit of the reference range for the respective gender and (if applicable) menopausal status. High sensitivity CRP ≥ 3x upper limit of the reference range, if suspected by the investigator to be indicative of inflammation. Albuminuria as defined by urine albumin/creatinine ratio > 30 mg/g. Proteinuria as defined by urine protein/creatinine ratio >200 mg/g. Presence of ≥1+ blood on urine dipstick or red blood cells on urine microscopy. A single repeat assessment for urine dipstick is allowed and, if negative, prior dipstick result will not be exclusionary.
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, PLACEBOCONTROLLED, SINGLE-DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-07940369 IN HEALTHY ADULT PARTICIPANTS
The purpose of the study is to evaluate the safety, tolerability, and Pharmacokinetics (Pharmacokinetics [PK] to better understand how the drug is changed and eliminated from your body after you take it) of single ascending oral doses of PF-07940369 in healthy adult participants.
This study is seeking participants who:
Read more
- are male or female that are not of childbearing potential of 18 years of age or older
- are examined to be healthy
All participants will receive up to 4 single doses of PF-07940369 and up to 2 placebo doses. All treatments will be taken by mouth.
All participants will remain in the study clinic for 4 days for each treatment, for safety review, laboratory collections, and to collect samples for PK.
All participants selected in the study will be required to go through a screening period up to 28 days. A screening period is the time during which a few participants are examined to see whether they are fit for the study. During this period, the participant's medical history and past and current medications will be reviewed. A series of tests will also be performed to see if they are good to be selected for the study. If the participant meets all required criteria and are interested in continuing, the participant will be brought into the study clinic to stay overnight for 4 days for each treatment period. On day 4, the participant will be discharged. About 28 to 35 days after discharge following the final treatment, the participant will be contacted for a follow up visit either in person or by telephone. This is to check up on how the participant is doing and to conclude the study.
- Conditions
- Healthy
- 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
Bulk powder for extemporaneous preparation for oral solutions.
PlaceboDrug
Bulk powder for extemporaneous preparation for oral solutions
| Study group | Role | What they receive |
|---|---|---|
| PF-07940369 and Placebo (Cohort 1) | Experimental | Single dose administration of PF-07940369 and placebo; Within a cohort, participants will receive up to 4 oral doses of PF-07940369 and up to 2 doses of placebo. Receives: Drug: PF-07940369; Drug: Placebo |
| PF-07940369 and Placebo (Cohort 2) | Placebo comparator | Single dose administration of PF-07940369 and placebo; Within a cohort, participants will receive up to 4 oral doses of PF-07940369 and up to 2 doses of placebo. 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 Treatment-Related Adverse Events (AEs)
Measured: Baseline (Day 0) up to 35 days after last dose of study medication
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Measured: Baseline up to Day 4
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Measured: Baseline up to Day 4
Number of Participants With Clinically Significant Change From Baseline in Telemetry Findings
Measured: Baseline up to Day 4
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
Measured: Baseline up to Day 4
Secondary outcomes (5)
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-07940369
Measured: Hour 0, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 24, 36, 48, and 72 post-dose in each period
Maximum Observed Plasma Concentration (Cmax) of PF-07940369
Measured: Hour 0, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 24, 36, 48, and 72 post-dose in each period
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07940369
Measured: Hour 0, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 24, 36, 48, and 72 post-dose in each period
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07940369
Measured: Hour 0, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 24, 36, 48, and 72 post-dose in each period
Plasma Half-Life (t1/2) of PF-07940369
Measured: Hour 0, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 24, 36, 48, and 72 post-dose in each period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start14 Aug 2024
- Primary completion16 Jan 2025
- Study completion16 Jan 2025
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
- Model description
- randomized, double-blinded (investigator- and participant-blinded), sponsor-open, placebo-controlled, 4-period, crossover, interleaving, first in human single ascending oral dose
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 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
- NCT06532383
- Sponsor's protocol ID
- C5381001
- Other IDs
- 2024-513467-47-00
- Status last verified
- Aug 2025
- First submitted
- 29 Jul 2024
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBOCONTROLLED, SINGLE-DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-07940369 IN HEALTHY ADULT PARTICIPANTS
- ClinicalTrials.gov ID
- NCT06532383
- Acronym / sponsor ID
- C5381001
- Conditions
- Healthy
- Keywords
- Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- 16 Jan 2025 (actual)
- Study completion
- 16 Jan 2025 (actual)
- First posted
- 1 Aug 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 purpose of the study is to evaluate the safety, tolerability, and Pharmacokinetics (Pharmacokinetics [PK] to better understand how the drug is changed and eliminated from your body after you take it) of single ascending oral doses of PF-07940369 in healthy adult participants.
This study is seeking participants who:
- are male or female that are not of childbearing potential of 18 years of age or older
- are examined to be healthy
All participants will receive up to 4 single doses of PF-07940369 and up to 2 placebo doses. All treatments will be taken by mouth.
All participants will remain in the study clinic for 4 days for each treatment, for safety review, laboratory collections, and to collect samples for PK.
All participants selected in the study will be required to go through a screening period up to 28 days. A screening period is the time during which a few participants are examined to see whether they are fit for the study. During this period, the participant's medical history and past and current medications will be reviewed. A series of tests will also be performed to see if they are good to be selected for the study. If the participant meets all required criteria and are interested in continuing, the participant will be brought into the study clinic to stay overnight for 4 days for each treatment period. On day 4, the participant will be discharged. About 28 to 35 days after discharge following the final treatment, the participant will be contacted for a follow up visit either in person or by telephone. This is to check up on how the participant is doing and to conclude the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- randomized, double-blinded (investigator- and participant-blinded), sponsor-open, placebo-controlled, 4-period, crossover, interleaving, first in human single ascending oral dose
| Arm | Type | Receives |
|---|---|---|
| PF-07940369 and Placebo (Cohort 1) | Experimental | Drug: PF-07940369, Drug: PlaceboSingle dose administration of PF-07940369 and placebo; Within a cohort, participants will receive up to 4 oral doses of PF-07940369 and up to 2 doses of placebo. |
| PF-07940369 and Placebo (Cohort 2) | Placebo comparator | Drug: PF-07940369, Drug: PlaceboSingle dose administration of PF-07940369 and placebo; Within a cohort, participants will receive up to 4 oral doses of PF-07940369 and up to 2 doses of placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants are eligible to be included in the study only if all of the following criteria apply:
- -Male participants and female participants who are not of childbearing potential who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, blood pressure, pulse rate and standard 12 lead ECG.
Key exclusion criteria (8 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- Any of the following conditions: History of iron storage diseases such as hemochromatosis. History of iron utilization disorder such as sideroblastic anemia. Diagnosis of hemolytic anemia or hemoglobinopathy (eg thalassemia). Diagnosis of iron deficiency anemia within 3 months prior to screening. Recent blood donation (within 60 days prior to first dose).
- History of intravenous iron therapy, erythropoiesis stimulating agent therapy (eg erythropoietin) and/or oral iron containing concomitant medications or nutritional supplements exceeding recommended dietary allowances for iron in adults (adult men age 19-50 years: 8 mg, adult women 19-50 years: 18 mg, adults >50 years: 8 mg on weekly average in the 4 weeks prior to randomization).
- 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 <90 mL/min/1.73m², as determined by the CKD-EPI equation using Screat calculated using the recommended formulas
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-07940369Bulk powder for extemporaneous preparation for oral solutions. | Drug | PF-07940369 and Placebo (Cohort 1), PF-07940369 and Placebo (Cohort 2) |
| PlaceboBulk powder for extemporaneous preparation for oral solutions | Drug | PF-07940369 and Placebo (Cohort 1), PF-07940369 and Placebo (Cohort 2) |
Primary outcome
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Time frame: Baseline (Day 0) up to 35 days after last dose of study medication
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Time frame: Baseline up to Day 4
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: Baseline up to Day 4
Number of Participants With Clinically Significant Change From Baseline in Telemetry Findings
Time frame: Baseline up to Day 4
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
Time frame: Baseline up to Day 4
5 secondary outcomes
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-07940369
Time frame: Hour 0, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 24, 36, 48, and 72 post-dose in each period
Maximum Observed Plasma Concentration (Cmax) of PF-07940369
Time frame: Hour 0, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 24, 36, 48, and 72 post-dose in each period
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07940369
Time frame: Hour 0, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 24, 36, 48, and 72 post-dose in each period
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07940369
Time frame: Hour 0, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 24, 36, 48, and 72 post-dose in each period
Plasma Half-Life (t1/2) of PF-07940369
Time frame: Hour 0, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 24, 36, 48, and 72 post-dose in each period
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 28 Aug 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-07940369 in people with Healthy, run by Pfizer at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 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 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Treatment-Related Adverse Events (AEs) (time frame: Baseline (Day 0) up to 35 days after last dose of study medication). The study lists 5 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 28 Aug 2025.