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

Study identifier:D1346C00015

ClinicalTrials.gov identifier:NCT05101148

EudraCT identifier:2020-005648-52

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase I, Single-Arm, Sequential Study to Evaluate the Effect of Food on the Gastrointestinal Tolerability and Pharmacokinetics of Selumetinib after Multiple Doses in Adolescent Children with Neurofibromatosis Type 1 Related Plexiform Neurofibromas

Medical condition

Neurofibromatosis Type 1

Phase

Phase 1

Healthy volunteers

No

Study drug

Selumetinib

Sex

All

Actual Enrollment

24

Study type

Interventional

Age

12 Years - 17 Years

Date

Study Start Date: 21 Jul 2021
Primary Completion Date: 06 Apr 2022
Estimated Study Completion Date: 12 Jan 2026

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Merck Sharp & Dohme Corp.

Inclusion and exclusion criteria