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 (NCT05101148)
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
🩺 Plain-English Summary (8th-Grade Level)
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 tolerability 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.
Who can join: Review the eligibility criteria below.
Location: Research Site — Rochester, Minnesota
Age range: 12 Years to 17 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (9 Sites)
- Research Site — Rochester, Minnesota
- Research Site — Akron, Ohio
- Research Site — Bydgoszcz,
- Research Site — Gdansk,
- Research Site — Warsaw,
- Research Site — Moscow,
- Research Site — Moscow,
- Research Site — Barcelona,
- Research Site — Madrid,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Neurofibromatosis Type 1
- Natural History Study of Patients With Neurofibromatosis Type I — Bethesda, Maryland
- Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children Aged ≥1 to <7 Years With NF1-related Symptomatic, Inoperable PN — Akron, Ohio
- Natural History Study of Cutaneous Neurofibromas in People With NF1 — Baltimore, Maryland
- Neurofibromatosis Type 1 Tumor Early Detection Study — Boston, Massachusetts
- Interventions for Reading Disabilities in NF1 — Nashville, Tennessee
Explore by condition: All Neurofibromatosis Type 1 clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.