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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05101148
The ClinicalTrials.gov registry entry for NCT05101148 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 159-participant average among 17 other Neurofibromatosis Type 1 trials with a reported enrollment target (85% lower). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
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 reports 9 study locations spanning 3 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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