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

NCT07731100 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: C4551008
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Adults

Keywords

Prifetrastat; Food Effect; PF-07248144

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (5)

• Number of participants with treatment-emergent adverse events

  Up to 28 to 35 days post last study intervention dose

• Number of participants with laboratory test abnormalities

  Up to 28 to 35 days post last study intervention dose

• Number of participants with vital signs values meeting categorical summarization criteria

  Up to 28 to 35 days post last study intervention dose

• Number of participants with clinically significant physical examination abnormalities

  Up to 28 to 35 days post last study intervention dose

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

  Up to 28 to 35 days post last study intervention dose

Study Arms (2)

Sequence AB

EXPERIMENTAL

Period 1 (Treatment A) : PF-07248144 single dose following an overnight fast Period 2 (Treatment B): PF-07248144 single dose following a high-fat, high-calorie meal Treatments A and B will be separated with a washout of at least 14 days

Drug: Prifetrastat

Sequence BA

EXPERIMENTAL

Period 1 (Treatment B): PF-07248144 single dose following a high-fat, high-calorie meal Period 2 (Treatment A): PF-07248144 single dose following an overnight fast Treatments B and A will be separated with a washout of at least 14 days

Drug: Prifetrastat

Interventions

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

Also known as: PF-07248144

Sequence AB; Sequence BA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

Location

Related Links

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 28, 2026
• Study Start: July 24, 2026
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): October 2, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)