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

Conditions

• Healthy Adults

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

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

Study Details

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.

Key Dates

First listed

Jul 28, 2026

Start date

Jul 24, 2026

Status verified

Jul 2026

Primary completion

Sep 10, 2026

Completion

Oct 2, 2026

Study Design

Enrollment

12 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Sequence AB
  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
• Experimental: Sequence BA
  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

Primary Outcome Measure

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 ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (1)

Find similar trials in New Haven, CT

Related Studies

• A Study to Learn About mRNA Vaccines Against Influenza in Adults
  PHASE2 · Recruiting · Pfizer · Mobile, Alabama
• A Study to Learn How Different Forms of the Study Medicine Called PF-08049820 Are Absorbed and Eliminated in Healthy Adults
  PHASE1 · Recruiting · Pfizer · New Haven, Connecticut
• A Study to Learn How Different Amounts of the Study Medicine Called PF-08103402 Are Tolerated and Act in the Body in Healthy Adults or Adults With Mild To-moderate Asthma
  PHASE1 · Recruiting · Pfizer · New Haven, Connecticut
• Effect of Acute Nitrate Supplementation on Vascular Function in Hispanic, Black and White Population
  Recruiting · University of Texas at Austin · Austin, Texas