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, 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:

• 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 Overview

• Status: Completed
• Conditions: Healthy Adults
• Intervention / Treatment: Drug: Placebo; Drug: PF-07940369

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles-capitale, Région de
    • Brussels, Bruxelles-capitale, Région de, Belgium, B-1070
      • Pfizer Clinical Research Unit - Brussels

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1, PF-07940369 or Placebo; Multiple oral dosing	Drug: Placebo; Oral Tablets; Drug: PF-07940369; Oral Tablets
Experimental: Cohort 2, PF-07940369 or Placebo; Multiple oral dosing	Drug: Placebo; Oral Tablets; Drug: PF-07940369; Oral Tablets
Experimental: Cohort 3, PF-07940369 or Placebo; Multiple oral dosing	Drug: Placebo; Oral Tablets; Drug: PF-07940369; Oral Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Treatment Emergent Adverse Events (AEs)	Baseline (Day 0) up to 35 days after last dose of study drug

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) of PF-07940369		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		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.	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%	0 to 12 hours or 0 to 24 hours post-dose

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2025
• Primary Completion (Actual): January 6, 2026
• Study Completion (Actual): January 6, 2026

Study Registration Dates

• First Submitted: July 3, 2025
• First Submitted That Met QC Criteria: April 5, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 5, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Healthy volunteers
• Other Study ID Numbers: C5381002; 2025-520558-12-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No