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NCT05101148 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Neurofibromatosis Type 1, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 9
- Study locations
NCT05101148: Active Phase 1 study of Neurofibromatosis Type 1, sponsored by AstraZeneca.
NCT05101148 is a Phase 1 study of Neurofibromatosis Type 1 that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 24 participants, below the 159-participant average among 17 other Neurofibromatosis Type 1 trials with a reported enrollment target (85% lower). The trial reports 9 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05101148, a Phase 1 study of Neurofibromatosis Type 1, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 9
- Study locations
Study 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 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.
Primary Outcome
To compare the AUC0-12, SS of the fed (same dose and dose adjustment if necessary) versus fasted state
Conditions Studied
Interventions
- DRUG Selumetinib
Study Locations (9)
Other
- Research Site - Bydgoszcz
- Research Site - Gdansk
- Research Site - Warsaw
- Research Site - Moscow
- Research Site - Moscow
- Research Site - Barcelona
- Research Site - Madrid
Minnesota
- Research Site - Rochester
Ohio
- Research Site - Akron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2021-07-21 |
| Est. Completion | 2028-04-28 |
| Phase | Phase 1 |
What the registry record for NCT05101148 still lists
NCT05101148 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 159-participant average among 17 other Neurofibromatosis Type 1 trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Neurofibromatosis Type 1 appearing as the primary indexed condition, and to 1 intervention - of which Selumetinib is the first listed.
NCT05101148 lists 9 locations in 3 states (Other, Minnesota, Ohio).
Frequently Asked Questions
What is clinical trial NCT05101148 about?
NCT05101148 is a clinical study titled "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 appropria...
What is the current status of trial NCT05101148?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2021-07-21. Estimated completion is 2028-04-28.
What conditions does trial NCT05101148 study?
This clinical trial studies the following conditions: Neurofibromatosis Type 1.
What interventions are being tested in trial NCT05101148?
The interventions under investigation include: Selumetinib (DRUG).
Who is sponsoring clinical trial NCT05101148?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05101148 being conducted?
This trial has 9 study locations across Minnesota, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neurofibromatosis Type 1
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05101148's enrollment target sits among peer trials
24 15th of 17 higher than 3 of 17 other Neurofibromatosis Type 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neurofibromatosis Type 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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