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NCT05309668 · ClinicalTrials.gov registry record · Phase 1

Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children Aged ≥1 to <7 Years With NF1-related Symptomatic, Inoperable PN

A Phase 1 study of Neurofibromatosis Type 1, sponsored by AstraZeneca.

Active
Registry status
Phase 1
Development phase
36
Enrollment target
16
Study locations

NCT05309668 is a Phase 1 study of Neurofibromatosis Type 1 that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 36 participants, below the 158-participant average among 17 other Neurofibromatosis Type 1 trials with a reported enrollment target (77% lower). The trial reports 16 study locations across 5 states.

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The verdict

NCT05309668, 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
36 participants
Enrollment target
16
Study locations

Study Summary

This study is designed to define a dosing regimen and assess the pharmacokinetics(PK) and safety of the granule formulation; the study will also include descriptive analyses of exploratory efficacy endpoints. The study will inform the benefit risk profile of the granule formulation in children aged ≥ 1 to \< 7 years with NF1 related symptomatic, inoperable PN.

Conditions Studied

Neurofibromatosis Type 1

Interventions

  • DRUG Selumetinib granule formulation
  • DRUG Selumetinib capsule formulation

Study Locations (16)

Other

  • Research Site - Hamburg
  • Research Site - München
  • Research Site - Tübingen
  • Research Site - Milan
  • Research Site - Rome
  • Research Site - Nagoya
  • Research Site - Setagaya City
  • Research Site - Rotterdam
  • Research Site - Moscow
  • Research Site - Moscow
  • Research Site - Barcelona
  • Research Site - Madrid

Ohio

  • Research Site - Akron

Pennsylvania

  • Research Site - Philadelphia

Texas

  • Research Site - Houston

Virginia

  • Research Site - Richmond

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2022-01-21
Est. Completion 2028-04-28
Phase Phase 1

Sponsor

AstraZeneca

1,285 total trials

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What the Registry Record Tells You About NCT05309668

The ClinicalTrials.gov registry entry for NCT05309668 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 158-participant average among 17 other Neurofibromatosis Type 1 trials with a reported enrollment target (77% 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 2 interventions - of which Selumetinib granule formulation is the first listed.

NCT05309668 reports 16 study locations spanning 5 distinct geographic areas - top geographies include Other, Ohio, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT05309668 about?

NCT05309668 is a clinical study titled "Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children Aged ≥1 to <7 Years With NF1-related Symptomatic, Inoperable PN". This study is designed to define a dosing regimen and assess the pharmacokinetics(PK) and safety of the granule formulation; the study will also include descriptive analyses of exploratory efficacy endpoints. The study will inform the benefit risk profile of the granule formulation in children aged ...

What is the current status of trial NCT05309668?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2022-01-21. Estimated completion is 2028-04-28.

What conditions does trial NCT05309668 study?

This clinical trial studies the following conditions: Neurofibromatosis Type 1.

What interventions are being tested in trial NCT05309668?

The interventions under investigation include: Selumetinib granule formulation (DRUG), Selumetinib capsule formulation (DRUG).

Who is sponsoring clinical trial NCT05309668?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05309668 being conducted?

This trial has 16 study locations across Ohio, Pennsylvania, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.