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NCT05309668 · OUTCOME

Selumetinib and N-desmethyl Selumetinib Dose Normalised AUC0-12 After Single and Multiple 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)/mg
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Pre-dose and 1, 2, 3, 4, 6, 8, 10-12, and 18-24 hours post-dose after selumetinib single dose on the first day of treatment (Cycle 1 Day 1). Pre-dose and 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 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 115
Global Cohort 217
Total in Global32
Japan Cohort4

Reported measurements

Cycle 1 Day 1: Selumetinib

Analysis denominator · Participants

GroupSource count
Global Cohort 113
Global Cohort 215
Total in Global28
Japan Cohort4
Values in (h*ng/mL)/mg · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Global Cohort 197.7323.21Not reportedNot reportedNot reported
Global Cohort 2131.433.44Not reportedNot reportedNot reported
Total in Global114.532.58Not reportedNot reportedNot reported
Japan Cohort112.646.45Not reportedNot reportedNot reported
Cycle 1 Day 1: N-desmethyl selumetinib

Analysis denominator · Participants

GroupSource count
Global Cohort 113
Global Cohort 213
Total in Global26
Japan Cohort4
Values in (h*ng/mL)/mg · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Global Cohort 18.01827.48Not reportedNot reportedNot reported
Global Cohort 210.3134.57Not reportedNot reportedNot reported
Total in Global9.09133.36Not reportedNot reportedNot reported
Japan Cohort8.71737.98Not reportedNot reportedNot reported
Cycle 2 Day 1: Selumetinib

Analysis denominator · Participants

GroupSource count
Global Cohort 115
Global Cohort 214
Total in Global29
Japan Cohort4
Values in (h*ng/mL)/mg · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Global Cohort 1162.250.01Not reportedNot reportedNot reported
Global Cohort 2165.348.38Not reportedNot reportedNot reported
Total in Global163.748.25Not reportedNot reportedNot reported
Japan Cohort144.026.97Not reportedNot reportedNot reported
Cycle 2 Day 1: N-desmethyl selumetinib

Analysis denominator · Participants

GroupSource count
Global Cohort 114
Global Cohort 214
Total in Global29
Japan Cohort4
Values in (h*ng/mL)/mg · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Global Cohort 19.93530.66Not reportedNot reportedNot reported
Global Cohort 210.6332.24Not reportedNot reportedNot reported
Total in Global10.2731.05Not reportedNot reportedNot reported
Japan Cohort10.5722.24Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.21
        value
        97.73
      2. group Id
        OG001
        spread
        33.44
        value
        131.4
      3. group Id
        OG002
        spread
        32.58
        value
        114.5
      4. group Id
        OG003
        spread
        46.45
        value
        112.6
    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
        4
      units
      Participants
    title
    Cycle 1 Day 1: Selumetinib
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        27.48
        value
        8.018
      2. group Id
        OG001
        spread
        34.57
        value
        10.31
      3. group Id
        OG002
        spread
        33.36
        value
        9.091
      4. group Id
        OG003
        spread
        37.98
        value
        8.717
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        26
      4. group Id
        OG003
        value
        4
      units
      Participants
    title
    Cycle 1 Day 1: N-desmethyl selumetinib
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        50.01
        value
        162.2
      2. group Id
        OG001
        spread
        48.38
        value
        165.3
      3. group Id
        OG002
        spread
        48.25
        value
        163.7
      4. group Id
        OG003
        spread
        26.97
        value
        144.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        14
      3. group Id
        OG002
        value
        29
      4. group Id
        OG003
        value
        4
      units
      Participants
    title
    Cycle 2 Day 1: Selumetinib
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.66
        value
        9.935
      2. group Id
        OG001
        spread
        32.24
        value
        10.63
      3. group Id
        OG002
        spread
        31.05
        value
        10.27
      4. group Id
        OG003
        spread
        22.24
        value
        10.57
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        14
      3. group Id
        OG002
        value
        29
      4. group Id
        OG003
        value
        4
      units
      Participants
    title
    Cycle 2 Day 1: N-desmethyl selumetinib
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      17
    3. group Id
      OG002
      value
      32
    4. group Id
      OG003
      value
      4
    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 post-dose after selumetinib single dose on the first day of treatment (Cycle 1 Day 1). Pre-dose and 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days)
title
Selumetinib and N-desmethyl Selumetinib Dose Normalised AUC0-12 After Single and Multiple Dose Administration
type
OTHER_PRE_SPECIFIED
unit Of Measure
(h*ng/mL)/mg

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Preserved source evidence · Not medical advice