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NCT04165031 · OUTCOME

Phase 1: Pharmacokinetics (PK): Average Concentration of LY3499446

A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation · Source last updated 2021-11-24

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 (ng/mL)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1 Day 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 8, 24 hours post-dose

What was measured

Average concentration after the first dose of LY3499446.

Analysis population: All participants who have received at least one dose of study drug and had evaluable PK.

Groups in this outcome

LY3499446 Phase 1 Cohort A1 (High Dose)

Participants received high dose LY3499446 as oral monotherapy BID in 21-day cycles.

LY3499446 Phase 1 Cohort AO (Mid Dose)

Participant received mid dose LY3499446 as oral monotherapy once QOD in 21-day cycles.

LY3499446 Phase 1 Cohort A-2 (Low Dose)

Participants received low dose LY3499446 as oral monotherapy once QD in 21-day cycles.

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

Analysis denominator · Participants

GroupSource count
LY3499446 Phase 1 Cohort A1 (High Dose)2
LY3499446 Phase 1 Cohort AO (Mid Dose)1
LY3499446 Phase 1 Cohort A-2 (Low Dose)2

Reported measurements

Source class 1
Values in nanograms per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LY3499446 Phase 1 Cohort A1 (High Dose)NANANot reportedNot reportedN=2: Geometric mean and Geometric Coefficient of Variation were not calculated, individual values reported:1056 ng/mL and 570 ng/mL.
LY3499446 Phase 1 Cohort AO (Mid Dose)NANANot reportedNot reportedN=1: Geometric mean and Geometric Coefficient of Variation were not calculated, individual values reported: 865 ng/mL.
LY3499446 Phase 1 Cohort A-2 (Low Dose)NANANot reportedNot reportedN=2: Geometric mean and Geometric Coefficient of Variation were not calculated, individual values reported: 225 ng/mL and 116 ng/mL.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        N=2: Geometric mean and Geometric Coefficient of Variation were not calculated, individual values reported:1056 ng/mL and 570 ng/mL.
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        N=1: Geometric mean and Geometric Coefficient of Variation were not calculated, individual values reported: 865 ng/mL.
        group Id
        OG001
        spread
        NA
        value
        NA
      3. comment
        N=2: Geometric mean and Geometric Coefficient of Variation were not calculated, individual values reported: 225 ng/mL and 116 ng/mL.
        group Id
        OG002
        spread
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      2
    units
    Participants
description
Average concentration after the first dose of LY3499446.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received high dose LY3499446 as oral monotherapy BID in 21-day cycles.
    id
    OG000
    title
    LY3499446 Phase 1 Cohort A1 (High Dose)
  2. description
    Participant received mid dose LY3499446 as oral monotherapy once QOD in 21-day cycles.
    id
    OG001
    title
    LY3499446 Phase 1 Cohort AO (Mid Dose)
  3. description
    Participants received low dose LY3499446 as oral monotherapy once QD in 21-day cycles.
    id
    OG002
    title
    LY3499446 Phase 1 Cohort A-2 (Low Dose)
param Type
GEOMETRIC_MEAN
population Description
All participants who have received at least one dose of study drug and had evaluable PK.
reporting Status
POSTED
time Frame
Cycle 1 Day 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 8, 24 hours post-dose
title
Phase 1: Pharmacokinetics (PK): Average Concentration of LY3499446
type
SECONDARY
unit Of Measure
nanograms per milliliter (ng/mL)

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice