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NCT05309668 · OUTCOME

Selumetinib AUC0-12 Derived After Single Dose Administration

Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children Aged ≥1 to <7 Years With NF1-related Symptomatic, Inoperable PN · Source last updated 2026-08-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
GEOMETRIC_MEAN
Unit
h*ng/mL
Interval / dispersion
95% Confidence Interval
Time frame
Pre-dose and 1, 2, 3, 4, 6, 8 and 10-12 hours after selumetinib single dose on the first day of study treatment (Cycle 1 Day 1) (each cycle is 28 days)

What was measured

To determine the pharmacokinetics of selumetinib after administration of the selumetinib granule formulation

Analysis population: Pharmacokinetic analysis set was used for analysis. Japan Cohort was not considered for the primary endpoint analysis. Some records were excluded for given visits and analytes due to missing concentration data, issues taking the medication and usage of prohibited medications.

Groups in this outcome

Global Cohort 1

Global Cohort 1 (\>=4 to \<7 years)

Global Cohort 2

Global Cohort 2 (\>=1 to \<4 years)

Total in Global

Global Cohorts (\>=1 to \<7 years)

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Global Cohort 113
Global Cohort 215
Total in Global28

Reported measurements

Source class 1
Values in h*ng/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Global Cohort 11902Not reported16472197Not reported
Global Cohort 21699Not reported14362009Not reported
Total in Global1790Not reported16091993Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1647
        upper Limit
        2197
        value
        1902
      2. group Id
        OG001
        lower Limit
        1436
        upper Limit
        2009
        value
        1699
      3. group Id
        OG002
        lower Limit
        1609
        upper Limit
        1993
        value
        1790
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    2. group Id
      OG001
      value
      15
    3. group Id
      OG002
      value
      28
    units
    Participants
description
To determine the pharmacokinetics of selumetinib after administration of the selumetinib granule formulation
dispersion Type
95% Confidence Interval
groups
  1. description
    Global Cohort 1 (\>=4 to \<7 years)
    id
    OG000
    title
    Global Cohort 1
  2. description
    Global Cohort 2 (\>=1 to \<4 years)
    id
    OG001
    title
    Global Cohort 2
  3. description
    Global Cohorts (\>=1 to \<7 years)
    id
    OG002
    title
    Total in Global
param Type
GEOMETRIC_MEAN
population Description
Pharmacokinetic analysis set was used for analysis. Japan Cohort was not considered for the primary endpoint analysis. Some records were excluded for given visits and analytes due to missing concentration data, issues taking the medication and usage of prohibited medications.
reporting Status
POSTED
time Frame
Pre-dose and 1, 2, 3, 4, 6, 8 and 10-12 hours after selumetinib single dose on the first day of study treatment (Cycle 1 Day 1) (each cycle is 28 days)
title
Selumetinib AUC0-12 Derived After Single Dose Administration
type
PRIMARY
unit Of Measure
h*ng/mL

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice