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NCT02014116 · OUTCOME

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-τ]) of LY3009120 Cycle 1 Day 28

A Study of LY3009120 in Participants With Advanced Cancer or Cancer That Has Spread to Other Parts of Their Body · Source last updated 2019-12-27

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

Measure
GEOMETRIC_MEAN
Unit
ng*hr/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose

What was measured

PK: area under the concentration versus time curve from time 0 to the end of the twice daily dosing interval at steady state AUC\[0-τ\].

Analysis population: All participants in Part A who have received at least one dose of study drug and have evaluable PK data in Cycle 1, Day 28, per protocol.

Groups in this outcome

50 mg LY3009120

50 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.

100 mg LY3009120

100 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.

200 mg LY3009120

200 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.

300 mg LY3009120

300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.

400 mg LY3009120

400 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.

500 mg LY3009120

500 mg LY3009210 administered orally every 12 hours daily in a 28-day cycle.

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

Analysis denominator · Participants

GroupSource count
50 mg LY30091202
100 mg LY30091203
200 mg LY30091203
300 mg LY30091207
400 mg LY30091203
500 mg LY30091200

Reported measurements

Source class 1
Values in ng*hr/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
50 mg LY300912031201300Not reportedNot reportedNot reported
100 mg LY30091203100102Not reportedNot reportedNot reported
200 mg LY300912052007Not reportedNot reportedNot reported
300 mg LY3009120658047Not reportedNot reportedNot reported
400 mg LY3009120464018Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1300
        value
        3120
      2. group Id
        OG001
        spread
        102
        value
        3100
      3. group Id
        OG002
        spread
        7
        value
        5200
      4. group Id
        OG003
        spread
        47
        value
        6580
      5. group Id
        OG004
        spread
        18
        value
        4640
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      7
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      0
    units
    Participants
description
PK: area under the concentration versus time curve from time 0 to the end of the twice daily dosing interval at steady state AUC\[0-τ\].
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    50 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
    id
    OG000
    title
    50 mg LY3009120
  2. description
    100 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
    id
    OG001
    title
    100 mg LY3009120
  3. description
    200 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
    id
    OG002
    title
    200 mg LY3009120
  4. description
    300 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
    id
    OG003
    title
    300 mg LY3009120
  5. description
    400 mg LY3009120 administered orally every 12 hours daily in a 28-day cycle.
    id
    OG004
    title
    400 mg LY3009120
  6. description
    500 mg LY3009210 administered orally every 12 hours daily in a 28-day cycle.
    id
    OG005
    title
    500 mg LY3009120
param Type
GEOMETRIC_MEAN
population Description
All participants in Part A who have received at least one dose of study drug and have evaluable PK data in Cycle 1, Day 28, per protocol.
reporting Status
POSTED
time Frame
Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose
title
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-τ]) of LY3009120 Cycle 1 Day 28
type
SECONDARY
unit Of Measure
ng*hr/mL

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

Preserved source evidence · Not medical advice