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

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

Age range

18+ years

Sex

All

Healthy volunteers

Yes

Interventions

• Drug
  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

Location