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NCT05309668 · OUTCOME

Selumetinib and N-desmethyl Selumetinib Tmax Derived 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
MEDIAN
Unit
h
Interval / dispersion
Full Range
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). 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: Selumetinib

Analysis denominator · Participants

GroupSource count
Global Cohort 113
Global Cohort 215
Total in Global28
Japan Cohort4
Values in h · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Global Cohort 11.83Not reported0.832.98Not reported
Global Cohort 22.00Not reported1.003.88Not reported
Total in Global1.97Not reported0.833.88Not reported
Japan Cohort2.47Not reported1.022.95Not 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 h · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Global Cohort 11.83Not reported0.832.98Not reported
Global Cohort 22.02Not reported1.005.87Not reported
Total in Global2.00Not reported0.835.87Not reported
Japan Cohort2.47Not reported1.022.95Not 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 · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Global Cohort 12.00Not reported0.924.07Not reported
Global Cohort 21.97Not reported0.924.05Not reported
Total in Global2.00Not reported0.924.07Not reported
Japan Cohort1.05Not reported0.972.00Not 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 h · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Global Cohort 12.00Not reported0.924.07Not reported
Global Cohort 22.01Not reported0.924.05Not reported
Total in Global2.00Not reported0.924.07Not reported
Japan Cohort1.56Not reported0.982.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.83
        upper Limit
        2.98
        value
        1.83
      2. group Id
        OG001
        lower Limit
        1.00
        upper Limit
        3.88
        value
        2.00
      3. group Id
        OG002
        lower Limit
        0.83
        upper Limit
        3.88
        value
        1.97
      4. group Id
        OG003
        lower Limit
        1.02
        upper Limit
        2.95
        value
        2.47
    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
        lower Limit
        0.83
        upper Limit
        2.98
        value
        1.83
      2. group Id
        OG001
        lower Limit
        1.00
        upper Limit
        5.87
        value
        2.02
      3. group Id
        OG002
        lower Limit
        0.83
        upper Limit
        5.87
        value
        2.00
      4. group Id
        OG003
        lower Limit
        1.02
        upper Limit
        2.95
        value
        2.47
    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
        lower Limit
        0.92
        upper Limit
        4.07
        value
        2.00
      2. group Id
        OG001
        lower Limit
        0.92
        upper Limit
        4.05
        value
        1.97
      3. group Id
        OG002
        lower Limit
        0.92
        upper Limit
        4.07
        value
        2.00
      4. group Id
        OG003
        lower Limit
        0.97
        upper Limit
        2.00
        value
        1.05
    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
        lower Limit
        0.92
        upper Limit
        4.07
        value
        2.00
      2. group Id
        OG001
        lower Limit
        0.92
        upper Limit
        4.05
        value
        2.01
      3. group Id
        OG002
        lower Limit
        0.92
        upper Limit
        4.07
        value
        2.00
      4. group Id
        OG003
        lower Limit
        0.98
        upper Limit
        2.00
        value
        1.56
    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
Full Range
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
MEDIAN
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). 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
Selumetinib and N-desmethyl Selumetinib Tmax Derived After Single and Multiple Dose Administration
type
SECONDARY
unit Of Measure
h

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Preserved source evidence · Not medical advice