Overview

Phase I Study to Assess the Effect of Food on the PK and Gastrointestinal Toxicity of Selumetinib in Adolescent Children With Neurofibromatosis Type 1 Related Plexiform Neurofibromas

Status:
Recruiting

Trial end date:
2023-02-28

Target enrollment:

Participant gender:

Summary

This study in adolescent participants with NF1 who have inoperable PN is designed to evaluate the effect of a low fat meal on steady state selumetinib exposure; to assess the effect on GI toxicity when selumetinib is dosed under fed and fasted conditions; and potentially, to confirm an appropriate dosing recommendation of selumetinib with a low fat meal that maintains efficacy with acceptable safety. These results may support labelling statements with regard to posology and food.

Phase:

Phase 1

Details

Lead Sponsor:

AstraZeneca

Collaborator:

Merck Sharp & Dohme Corp.