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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
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.
Details
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | PHASE1 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 24 |
| Start date | Wed Jul 21 2021 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Fri Apr 28 2028 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Neurofibromatosis Type 1
Interventions
- Selumetinib
Countries
Spain, Russia, United States, Poland