Clinical Research Directory

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

Sponsor: Pfizer

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.

Official 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

Key Details

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Interventions

Locations (1)