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NCT05309668 · OUTCOME

Selumetinib Vz/F 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
L
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 112
Global Cohort 215
Total in Global27
Japan Cohort3

Reported measurements

Source class 1
Values in L · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Global Cohort 191.6333.64Not reportedNot reportedNot reported
Global Cohort 264.3344.81Not reportedNot reportedNot reported
Total in Global75.2843.86Not reportedNot reportedNot reported
Japan Cohort107.250.91Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        33.64
        value
        91.63
      2. group Id
        OG001
        spread
        44.81
        value
        64.33
      3. group Id
        OG002
        spread
        43.86
        value
        75.28
      4. group Id
        OG003
        spread
        50.91
        value
        107.2
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      15
    3. group Id
      OG002
      value
      27
    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 Vz/F Derived After Single Dose Administration
type
SECONDARY
unit Of Measure
L

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice