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NCT05309668 · OUTCOME

Parent-to-metabolite Ratio for AUC0-6, AUC0-12 and AUC0-24 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
Ratio
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 Cycle 1 Day 1. Pre-dose, 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: MPAUC0-6

Analysis denominator · Participants

GroupSource count
Global Cohort 113
Global Cohort 215
Total in Global28
Japan Cohort4
Values in Ratio · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Global Cohort 10.0780318.27Not reportedNot reportedNot reported
Global Cohort 20.0737915.50Not reportedNot reportedNot reported
Total in Global0.0757316.76Not reportedNot reportedNot reported
Japan Cohort0.0738612.37Not reportedNot reportedNot reported
Cycle 1 Day 1: MPAUC0-12

Analysis denominator · Participants

GroupSource count
Global Cohort 113
Global Cohort 213
Total in Global26
Japan Cohort4
Values in Ratio · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Global Cohort 10.0820417.91Not reportedNot reportedNot reported
Global Cohort 20.0772217.19Not reportedNot reportedNot reported
Total in Global0.0796017.48Not reportedNot reportedNot reported
Japan Cohort0.0774214.05Not reportedNot reportedNot reported
Cycle 1 Day 1: MPAUC0-24

Analysis denominator · Participants

GroupSource count
Global Cohort 113
Global Cohort 213
Total in Global26
Japan Cohort3
Values in Ratio · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Global Cohort 10.0820919.94Not reportedNot reportedNot reported
Global Cohort 20.0751618.93Not reportedNot reportedNot reported
Total in Global0.0785519.59Not reportedNot reportedNot reported
Japan Cohort0.079427.881Not reportedNot reportedNot reported
Cycle 2 Day 1: MPAUC0-6

Analysis denominator · Participants

GroupSource count
Global Cohort 115
Global Cohort 214
Total in Global29
Japan Cohort4
Values in Ratio · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Global Cohort 10.0603629.62Not reportedNot reportedNot reported
Global Cohort 20.0612326.61Not reportedNot reportedNot reported
Total in Global0.0607827.69Not reportedNot reportedNot reported
Japan Cohort0.0693420.71Not reportedNot reportedNot reported
Cycle 2 Day 1: MPAUC0-12

Analysis denominator · Participants

GroupSource count
Global Cohort 114
Global Cohort 214
Total in Global28
Japan Cohort4
Values in Ratio · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Global Cohort 10.0641329.74Not reportedNot reportedNot reported
Global Cohort 20.0642926.09Not reportedNot reportedNot reported
Total in Global0.0642127.42Not reportedNot reportedNot reported
Japan Cohort0.0733919.13Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.27
        value
        0.07803
      2. group Id
        OG001
        spread
        15.50
        value
        0.07379
      3. group Id
        OG002
        spread
        16.76
        value
        0.07573
      4. group Id
        OG003
        spread
        12.37
        value
        0.07386
    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: MPAUC0-6
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.91
        value
        0.08204
      2. group Id
        OG001
        spread
        17.19
        value
        0.07722
      3. group Id
        OG002
        spread
        17.48
        value
        0.07960
      4. group Id
        OG003
        spread
        14.05
        value
        0.07742
    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: MPAUC0-12
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.94
        value
        0.08209
      2. group Id
        OG001
        spread
        18.93
        value
        0.07516
      3. group Id
        OG002
        spread
        19.59
        value
        0.07855
      4. group Id
        OG003
        spread
        7.881
        value
        0.07942
    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
        3
      units
      Participants
    title
    Cycle 1 Day 1: MPAUC0-24
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        29.62
        value
        0.06036
      2. group Id
        OG001
        spread
        26.61
        value
        0.06123
      3. group Id
        OG002
        spread
        27.69
        value
        0.06078
      4. group Id
        OG003
        spread
        20.71
        value
        0.06934
    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: MPAUC0-6
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        29.74
        value
        0.06413
      2. group Id
        OG001
        spread
        26.09
        value
        0.06429
      3. group Id
        OG002
        spread
        27.42
        value
        0.06421
      4. group Id
        OG003
        spread
        19.13
        value
        0.07339
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        14
      3. group Id
        OG002
        value
        28
      4. group Id
        OG003
        value
        4
      units
      Participants
    title
    Cycle 2 Day 1: MPAUC0-12
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 after selumetinib single dose on Cycle 1 Day 1. Pre-dose, 1, 2, 3, 4, 6, 8, and 10-12 hours post-dose on Cycle 2 Day 1 (each cycle is 28 days)
title
Parent-to-metabolite Ratio for AUC0-6, AUC0-12 and AUC0-24 After Single and Multiple Dose Administration.
type
SECONDARY
unit Of Measure
Ratio

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Preserved source evidence · Not medical advice