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Completed

NCT Number: NCT07514156

A Study to Learn How Different Amounts of the Study Medicine Called PF-07940369 Are Tolerated and Act in the Body in Healthy Adults.

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.

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Key information

Conditions

Healthy Adults

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit - Brussels

Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-07940369

Drug

Oral Tablets

Placebo

Drug

Oral Tablets

Primary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events (AEs)

    Time frame: Baseline (Day 0) up to 35 days after last dose of study drug

Secondary outcomes

  1. 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

  2. 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

  3. 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

    Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval is 12 or 24 hours.

  4. Percent of Dose Recovered in Urine as Unchanged Drug (Aetau%)

    Time frame: 0 to 12 hours or 0 to 24 hours post-dose

    PF-07940369 urinary PK parameters: Aetau%

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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