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NCT05309668 · OUTCOME

Selumetinib and N-desmethyl Selumetinib AUC0-24 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
Geometric Coefficient of Variation
Time frame
Pre-dose and 1, 2, 3, 4, 6, 8, 10-12 and 18-24 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 further evaluate the PK of the granule formulation.

Analysis population: Pharmacokinetic analysis set was used for 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)

Japan Cohort

Japan Cohort (\>=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
Japan Cohort3

Reported measurements

Cycle 1 Day 1: Selumetinib

Analysis denominator · Participants

GroupSource count
Global Cohort 113
Global Cohort 215
Total in Global28
Japan Cohort3
Values in h*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Global Cohort 1222224.72Not reportedNot reportedNot reported
Global Cohort 2194229.73Not reportedNot reportedNot reported
Total in Global206727.91Not reportedNot reportedNot reported
Japan Cohort15687.648Not reportedNot reportedNot reported
Cycle 1 Day 1: N-desmethyl selumetinib

Analysis denominator · Participants

GroupSource count
Global Cohort 113
Global Cohort 213
Total in Global28
Japan Cohort3
Values in h*ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Global Cohort 1182.427.93Not reportedNot reportedNot reported
Global Cohort 2148.337.04Not reportedNot reportedNot reported
Total in Global164.533.92Not reportedNot reportedNot reported
Japan Cohort129.813.54Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.72
        value
        2222
      2. group Id
        OG001
        spread
        29.73
        value
        1942
      3. group Id
        OG002
        spread
        27.91
        value
        2067
      4. group Id
        OG003
        spread
        7.648
        value
        1568
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        15
      3. group Id
        OG002
        value
        28
      4. group Id
        OG003
        value
        3
      units
      Participants
    title
    Cycle 1 Day 1: Selumetinib
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        27.93
        value
        182.4
      2. group Id
        OG001
        spread
        37.04
        value
        148.3
      3. group Id
        OG002
        spread
        33.92
        value
        164.5
      4. group Id
        OG003
        spread
        13.54
        value
        129.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        28
      4. group Id
        OG003
        value
        3
      units
      Participants
    title
    Cycle 1 Day 1: N-desmethyl selumetinib
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    2. group Id
      OG001
      value
      15
    3. group Id
      OG002
      value
      28
    4. group Id
      OG003
      value
      3
    units
    Participants
description
To further evaluate the PK of the granule formulation.
dispersion Type
Geometric Coefficient of Variation
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
  4. description
    Japan Cohort (\>=1 to \<7 years)
    id
    OG003
    title
    Japan Cohort
param Type
GEOMETRIC_MEAN
population Description
Pharmacokinetic analysis set was used for 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, 10-12 and 18-24 hours after selumetinib single dose on the first day of study treatment (Cycle 1 Day 1) (each cycle is 28 days)
title
Selumetinib and N-desmethyl Selumetinib AUC0-24 Derived After Single Dose Administration
type
SECONDARY
unit Of Measure
h*ng/mL

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Preserved source evidence · Not medical advice