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NCT04975308 · OUTCOME

Pharmacokinetics (PK): Plasma Concentration of Total Abemaciclib

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

* Plasma concentration of total abemaciclib is the concentration of the parent abemaciclib and its metabolites in the plasma. * 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 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 C: Imlunestrant + Abemaciclib176

Reported measurements

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

Analysis denominator · Participants

GroupSource count
Arm C: Imlunestrant + Abemaciclib176
Values in nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Arm C: Imlunestrant + Abemaciclib158120Not reportedNot reportedNot reported
Cycle 2 Day 1 (Predose)

Analysis denominator · Participants

GroupSource count
Arm C: Imlunestrant + Abemaciclib129
Values in nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Arm C: Imlunestrant + Abemaciclib79282Not reportedNot reportedNot reported
Cycle 3 Day 1 (3 hours post-dose)

Analysis denominator · Participants

GroupSource count
Arm C: Imlunestrant + Abemaciclib100
Values in nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Arm C: Imlunestrant + Abemaciclib88074Not reportedNot reportedNot reported
Cycle 3 Day 1 (5 hours post-dose)

Analysis denominator · Participants

GroupSource count
Arm C: Imlunestrant + Abemaciclib100
Values in nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Arm C: Imlunestrant + Abemaciclib92664Not reportedNot reportedNot reported
Cycle 4 Day 1 (Predose)

Analysis denominator · Participants

GroupSource count
Arm C: Imlunestrant + Abemaciclib79
Values in nanograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Arm C: Imlunestrant + Abemaciclib78359Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        120
        value
        158
    denoms
    1. counts
      1. group Id
        OG000
        value
        176
      units
      Participants
    title
    Cycle 1 Day 1 (within 2 to 4 hours postdose)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        82
        value
        792
    denoms
    1. counts
      1. group Id
        OG000
        value
        129
      units
      Participants
    title
    Cycle 2 Day 1 (Predose)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        74
        value
        880
    denoms
    1. counts
      1. group Id
        OG000
        value
        100
      units
      Participants
    title
    Cycle 3 Day 1 (3 hours post-dose)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        64
        value
        926
    denoms
    1. counts
      1. group Id
        OG000
        value
        100
      units
      Participants
    title
    Cycle 3 Day 1 (5 hours post-dose)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        59
        value
        783
    denoms
    1. counts
      1. group Id
        OG000
        value
        79
      units
      Participants
    title
    Cycle 4 Day 1 (Predose)
denoms
  1. counts
    1. group Id
      OG000
      value
      176
    units
    Participants
description
* Plasma concentration of total abemaciclib is the concentration of the parent abemaciclib and its metabolites in the plasma. * 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 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
    OG000
    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 Total Abemaciclib
type
SECONDARY
unit Of Measure
nanograms per milliliter

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Preserved source evidence · Not medical advice