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NCT02014116 · OUTCOME

Pharmacokinetics (PK): Maximum Concentration (Cmax) 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/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: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 28.

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 LY3009120 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/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
50 mg LY3009120587.75206.15Not reportedNot reportedNot reported
100 mg LY3009120550113Not reportedNot reportedNot reported
200 mg LY300912059432Not reportedNot reportedNot reported
300 mg LY3009120115069Not reportedNot reportedNot reported
400 mg LY300912067030Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        206.15
        value
        587.75
      2. group Id
        OG001
        spread
        113
        value
        550
      3. group Id
        OG002
        spread
        32
        value
        594
      4. group Id
        OG003
        spread
        69
        value
        1150
      5. group Id
        OG004
        spread
        30
        value
        670
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: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 28.
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 LY3009120 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): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 28
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice