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NCT04975308 · OUTCOME

Pharmacokinetics (PK): Plasma Concentration of Imlunestrant

A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer · Source last updated 2026-07-22

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
GEOMETRIC_MEAN
Unit
nanograms per milliliter
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1 Day 1 (within 2 to 4 hours post-dose), Cycle 2 Day 1 (Predose), Cycle 3 Day 1 (3 hours post-dose, 5 hours post-dose), Cycle 4 Day 1 (Predose)

What was measured

* Sampling timepoints for PK outcome analysis were relative to Imlunestrant dosing. * For Cycle 1 Day 1, sampling occurred at a "single" timepoint within the 2- to 4-hour window after Imlunestrant dosing, with the timepoint varying across analyzed participants.

Analysis population: All randomised participants who received at least 1 dose of study drug and had evaluable PK data for this outcome.

Groups in this outcome

Arm A: Imlunestrant

Participants received Imlunestrant 400 milligrams (mg) orally once daily on days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation were met.

Arm C: Imlunestrant + Abemaciclib

Participants received Imlunestrant 400 mg orally once daily on Days 1 to 28 of a 28-day cycle, plus Abemaciclib 150 mg orally twice daily on Days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation was met.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm A: Imlunestrant276
Arm C: Imlunestrant + Abemaciclib189

Reported measurements

Cycle 1 Day 1 (within 2 to 4 hours postdose)

Analysis denominator · Participants

GroupSource count
Arm A: Imlunestrant276
Arm C: Imlunestrant + Abemaciclib189
Values in nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Arm A: Imlunestrant45.7123Not reportedNot reportedNot reported
Arm C: Imlunestrant + Abemaciclib56.5122Not reportedNot reportedNot reported
Cycle 2 Day 1 (Predose)

Analysis denominator · Participants

GroupSource count
Arm A: Imlunestrant269
Arm C: Imlunestrant + Abemaciclib140
Values in nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Arm A: Imlunestrant7676Not reportedNot reportedNot reported
Arm C: Imlunestrant + Abemaciclib64.9103Not reportedNot reportedNot reported
Cycle 3 Day 1 (3 hours post-dose)

Analysis denominator · Participants

GroupSource count
Arm A: Imlunestrant219
Arm C: Imlunestrant + Abemaciclib125
Values in nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Arm A: Imlunestrant14170Not reportedNot reportedNot reported
Arm C: Imlunestrant + Abemaciclib14473Not reportedNot reportedNot reported
Cycle 3 Day 1 (5 hours post-dose)

Analysis denominator · Participants

GroupSource count
Arm A: Imlunestrant209
Arm C: Imlunestrant + Abemaciclib123
Values in nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Arm A: Imlunestrant13669Not reportedNot reportedNot reported
Arm C: Imlunestrant + Abemaciclib14669Not reportedNot reportedNot reported
Cycle 4 Day 1 (Predose)

Analysis denominator · Participants

GroupSource count
Arm A: Imlunestrant178
Arm C: Imlunestrant + Abemaciclib105
Values in nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Arm A: Imlunestrant85.269Not reportedNot reportedNot reported
Arm C: Imlunestrant + Abemaciclib6397Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        123
        value
        45.7
      2. group Id
        OG001
        spread
        122
        value
        56.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        276
      2. group Id
        OG001
        value
        189
      units
      Participants
    title
    Cycle 1 Day 1 (within 2 to 4 hours postdose)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        76
        value
        76
      2. group Id
        OG001
        spread
        103
        value
        64.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        269
      2. group Id
        OG001
        value
        140
      units
      Participants
    title
    Cycle 2 Day 1 (Predose)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        70
        value
        141
      2. group Id
        OG001
        spread
        73
        value
        144
    denoms
    1. counts
      1. group Id
        OG000
        value
        219
      2. group Id
        OG001
        value
        125
      units
      Participants
    title
    Cycle 3 Day 1 (3 hours post-dose)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        69
        value
        136
      2. group Id
        OG001
        spread
        69
        value
        146
    denoms
    1. counts
      1. group Id
        OG000
        value
        209
      2. group Id
        OG001
        value
        123
      units
      Participants
    title
    Cycle 3 Day 1 (5 hours post-dose)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        69
        value
        85.2
      2. group Id
        OG001
        spread
        97
        value
        63
    denoms
    1. counts
      1. group Id
        OG000
        value
        178
      2. group Id
        OG001
        value
        105
      units
      Participants
    title
    Cycle 4 Day 1 (Predose)
denoms
  1. counts
    1. group Id
      OG000
      value
      276
    2. group Id
      OG001
      value
      189
    units
    Participants
description
* Sampling timepoints for PK outcome analysis were relative to Imlunestrant dosing. * For Cycle 1 Day 1, sampling occurred at a "single" timepoint within the 2- to 4-hour window after Imlunestrant dosing, with the timepoint varying across analyzed participants.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received Imlunestrant 400 milligrams (mg) orally once daily on days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation were met.
    id
    OG000
    title
    Arm A: Imlunestrant
  2. description
    Participants received Imlunestrant 400 mg orally once daily on Days 1 to 28 of a 28-day cycle, plus Abemaciclib 150 mg orally twice daily on Days 1 to 28 of a 28-day cycle, until disease progression or a criterion for discontinuation was met.
    id
    OG001
    title
    Arm C: Imlunestrant + Abemaciclib
param Type
GEOMETRIC_MEAN
population Description
All randomised participants who received at least 1 dose of study drug and had evaluable PK data for this outcome.
reporting Status
POSTED
time Frame
Cycle 1 Day 1 (within 2 to 4 hours post-dose), Cycle 2 Day 1 (Predose), Cycle 3 Day 1 (3 hours post-dose, 5 hours post-dose), Cycle 4 Day 1 (Predose)
title
Pharmacokinetics (PK): Plasma Concentration of Imlunestrant
type
SECONDARY
unit Of Measure
nanograms per milliliter

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Preserved source evidence · Not medical advice