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NCT Number: NCT07731100

A Study to Learn About How Food Affects the Uptake of Study Medicine Prifetrastat Into the Blood in Healthy Adults

The purpose of the study is to assess the effect of food (high-fat, high-calorie meal) on the total and peak drug exposure of the planned to be marketed tablet formulation of prifetrastat.

This study is seeking participants who are:

- Healthy males and females of nonchildbearing potential ≥18 years of age at screening

The participants will receive study medicine prifetrastat as a single tablet by mouth at study clinic under fed or fasted condition. After at least 14 days, they will receive another single tablet of prifetrastat by mouth under fasted or fed condition. The sequence of conditions (fed or fasted first) will be randomized.

The results of this study will enable data-driven guidance regarding food intake for participants enrolled in clinical studies of prifetrastat as well as patients receiving prifetrastat post-marketing. Participants will remain in clinic for about 21 days and have one follow up contact.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Females of nonchildbearing potential and males ≥18 years of age at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs.
  • Body mass Index (BMI) of 18-32 kg/m2; and a total body weight >50 kg (110 lb).

Exclusion criteria

  • Use of prescription or nonprescription drugs and dietary and herbal supplements within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention
  • Any prior use of epigenetic modifying agents.
  • Current use or anticipated need for food or drugs that are known moderate or strong inducers or inhibitors of CYP2C9 or CYP3A4, including their administration within 14 days plus 5 half-lives of the inducers or 14 days or 5 half lives (whichever is longer) for the inhibitors of CYP2C9 or CYP3A4, prior to first dose of study intervention, during the treatment period, and within 6 days after the last dose of prifetrastat.
  • Proton pump inhibitors must be discontinued at least 14 days prior to the first dose of study medication and throughout treatment period.

Treatment and study plan

Prifetrastat

Drug

Participants will receive Prifetrastat as a single dose, oral tablet on Day 1 of Period 1 and Day 1 of Period 2 with a washout period between two doses

Other names: PF-07248144

Primary outcomes

  1. Area under the concentration-time curve from time zero to extrapolated infinite time (AUCinf) for Prifetrastat

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours post-dose

  2. Area under the concentration-time curve from time zero to time of last measurable concentration (AUClast) for Prifetrastat

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours post-dose

  3. Maximum observed plasma concentration (Cmax) for Prifetrastat

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours post-dose

Secondary outcomes

  1. Number of participants with treatment-emergent adverse events

    Time frame: Up to 28 to 35 days post last study intervention dose

  2. Number of participants with laboratory test abnormalities

    Time frame: Up to 28 to 35 days post last study intervention dose

  3. Number of participants with vital signs values meeting categorical summarization criteria

    Time frame: Up to 28 to 35 days post last study intervention dose

  4. Number of participants with clinically significant physical examination abnormalities

    Time frame: Up to 28 to 35 days post last study intervention dose

  5. Number of participants with treatment emergent clinically significant abnormal electrocardiogram (ECG) measurements

    Time frame: Up to 28 to 35 days post last study intervention dose

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 1, RANDOMIZED, OPEN-LABEL, 2-PERIOD, 2-SEQUENCE, SINGLE-DOSE, CROSSOVER STUDY IN HEALTHY PARTICIPANTS TO EVALUATE THE EFFECT OF FOOD ON THE RELATIVE BIOAVAILABILITY OF PRIFETRASTAT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2026
Registry last updated
Jul 28, 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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