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NCT05309668 · OUTCOME

Selumetinib and N-desmethyl Selumetinib BSA Normalised Cmax 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
(ng/mL)/m2
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 (ng/mL)/m2 · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Global Cohort 1719.247.70Not reportedNot reportedNot reported
Global Cohort 2840.955.12Not reportedNot reportedNot reported
Total in Global782.051.47Not reportedNot reportedNot reported
Japan Cohort1041110.3Not reportedNot reportedNot reported
Cycle 1 Day 1: N-desmethyl selumetinib

Analysis denominator · Participants

GroupSource count
Global Cohort 113
Global Cohort 215
Total in Global28
Japan Cohort4
Values in (ng/mL)/m2 · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Global Cohort 152.8948.40Not reportedNot reportedNot reported
Global Cohort 259.2352.39Not reportedNot reportedNot reported
Total in Global56.2049.93Not reportedNot reportedNot reported
Japan Cohort72.5981.41Not 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 (ng/mL)/m2 · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Global Cohort 1110146.84Not reportedNot reportedNot reported
Global Cohort 2913.156.39Not reportedNot reportedNot reported
Total in Global100651.65Not reportedNot reportedNot reported
Japan Cohort107232.38Not reportedNot reportedNot reported
Cycle 2 Day 1: N-desmethyl selumetinib

Analysis denominator · Participants

GroupSource count
Global Cohort 115
Global Cohort 214
Total in Global29
Japan Cohort4
Values in (ng/mL)/m2 · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Global Cohort 162.0639.05Not reportedNot reportedNot reported
Global Cohort 252.9045.74Not reportedNot reportedNot reported
Total in Global57.4642.46Not reportedNot reportedNot reported
Japan Cohort71.8939.02Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        47.70
        value
        719.2
      2. group Id
        OG001
        spread
        55.12
        value
        840.9
      3. group Id
        OG002
        spread
        51.47
        value
        782.0
      4. group Id
        OG003
        spread
        110.3
        value
        1041
    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
        48.40
        value
        52.89
      2. group Id
        OG001
        spread
        52.39
        value
        59.23
      3. group Id
        OG002
        spread
        49.93
        value
        56.20
      4. group Id
        OG003
        spread
        81.41
        value
        72.59
    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: N-desmethyl selumetinib
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        46.84
        value
        1101
      2. group Id
        OG001
        spread
        56.39
        value
        913.1
      3. group Id
        OG002
        spread
        51.65
        value
        1006
      4. group Id
        OG003
        spread
        32.38
        value
        1072
    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
        39.05
        value
        62.06
      2. group Id
        OG001
        spread
        45.74
        value
        52.90
      3. group Id
        OG002
        spread
        42.46
        value
        57.46
      4. group Id
        OG003
        spread
        39.02
        value
        71.89
    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: 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 BSA Normalised Cmax After Single and Multiple Dose Administration
type
OTHER_PRE_SPECIFIED
unit Of Measure
(ng/mL)/m2

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Preserved source evidence · Not medical advice