Overview

Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children Aged ≥1 to <7 Years With NF1-related Symptomatic, Inoperable PN

Status:
Recruiting

Trial end date:
2027-07-09

Target enrollment:

Participant gender:

Summary

This study is designed to define a dosing regimen and assess the pharmacokinetics(PK) and safety of the granule formulation; the study will also include descriptive analyses of exploratory efficacy endpoints. The study will inform the benefit risk profile of the granule formulation in children aged ≥ 1 to < 7 years with NF1 related symptomatic, inoperable PN.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

AstraZeneca

Collaborator:

Merck Sharp & Dohme Corp.