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

NCT07731100 · tracked via the Priya Life Science USA tracker

Sponsor

Pfizer

Phase

Phase 1

Started

2026-07-24

Last updated

2026-07-28

Condition(s) studied

Healthy Adults

Investigational drug(s) / intervention(s)

Prifetrastat →

Prifetrastat: 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

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Area under the concentration-time curve from time zero to extrapolated infinite time (AUCinf) for Prifetrastat — 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
Area under the concentration-time curve from time zero to time of last measurable concentration (AUClast) for Prifetrastat — 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
Maximum observed plasma concentration (Cmax) for Prifetrastat — 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

Trial sites (1)

Facility	City	Region	Status
Pfizer Clinical Research Unit - New Haven	New Haven	Connecticut

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07731100 on ClinicalTrials.gov ↗ ← All trials in the USA