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NCT02711345 · OUTCOME

The Maximum (Peak) Observed Plasma, Blood, Serum, or Other Body Fluid Drug Concentration (Cmax) After Single Dose Administration of LTT462

A Phase I Clinical Study With Investigational Compound LTT462 in Adult Patients With Specific Advanced Cancers. · Source last updated 2019-09-19

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

Measure
GEOMETRIC_MEAN
Unit
nanogram per milliliter (ng/mL)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
day 1, day 15

What was measured

Cmax is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration expressed in mass x volume-1.

Analysis population: Pharmacokinetic (PK) analysis set (PAS) included of all participants who have at least 1 PK blood sample providing measurable LTT462 and received at least 1 dose of study drug, didn't vomit within 4 hours postdose, had at least 1 primary PK parameter. Here 'n' number analyzed signifies number of participants who were evaluable at each time point.

Groups in this outcome

LTT462 45 mg QD

Participants received 45 mg LTT462 QD as oral capsules.

LTT462 100 mg QD

Participants received 100 mg LTT462 QD as oral capsules.

LTT462 150 mg QD

Participants received 150 mg LTT462 QD as oral capsules.

LTT462 200 mg QD

Participants received 200 mg LTT462 QD as oral capsules.

LTT462 300 mg QD

Participants received 300 mg LTT462 QD as oral capsules.

LTT462 400 mg QD

Participants received 400 mg LTT462 QD as oral capsules.

LTT462 450 mg QD

Participants received 450 mg LTT462 QD as oral capsules.

LTT462 600 mg QD

Participants received 600 mg LTT462 QD as oral capsules.

LTT462 150 mg BID

Participants received 150 mg LTT462 twice daily (BID) as oral capsules.

LTT462 200 mg BID

Participants received 200 mg LTT462 BID as oral capsules.

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

Analysis denominator · Participants

GroupSource count
LTT462 45 mg QD2
LTT462 100 mg QD3
LTT462 150 mg QD6
LTT462 200 mg QD4
LTT462 300 mg QD8
LTT462 400 mg QD6
LTT462 450 mg QD11
LTT462 600 mg QD4
LTT462 150 mg BID6
LTT462 200 mg BID12

Reported measurements

Day 1

Analysis denominator · Participants

GroupSource count
LTT462 45 mg QD2
LTT462 100 mg QD3
LTT462 150 mg QD6
LTT462 200 mg QD4
LTT462 300 mg QD7
LTT462 400 mg QD6
LTT462 450 mg QD10
LTT462 600 mg QD3
LTT462 150 mg BID5
LTT462 200 mg BID12
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LTT462 45 mg QD61.355.9Not reportedNot reportedNot reported
LTT462 100 mg QD13438.8Not reportedNot reportedNot reported
LTT462 150 mg QD218230.9Not reportedNot reportedNot reported
LTT462 200 mg QD494126.8Not reportedNot reportedNot reported
LTT462 300 mg QD717127.4Not reportedNot reportedNot reported
LTT462 400 mg QD158060.8Not reportedNot reportedNot reported
LTT462 450 mg QD142083.5Not reportedNot reportedNot reported
LTT462 600 mg QD128047.7Not reportedNot reportedNot reported
LTT462 150 mg BID59883.0Not reportedNot reportedNot reported
LTT462 200 mg BID57573.8Not reportedNot reportedNot reported
Day 15

Analysis denominator · Participants

GroupSource count
LTT462 45 mg QD2
LTT462 100 mg QD3
LTT462 150 mg QD5
LTT462 200 mg QD3
LTT462 300 mg QD6
LTT462 400 mg QD4
LTT462 450 mg QD8
LTT462 600 mg QD2
LTT462 150 mg BID5
LTT462 200 mg BID6
Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LTT462 45 mg QD13929.9Not reportedNot reportedNot reported
LTT462 100 mg QD93882.5Not reportedNot reportedNot reported
LTT462 150 mg QD70769.0Not reportedNot reportedNot reported
LTT462 200 mg QD97292.4Not reportedNot reportedNot reported
LTT462 300 mg QD1330131.9Not reportedNot reportedNot reported
LTT462 400 mg QD237083.3Not reportedNot reportedNot reported
LTT462 450 mg QD347049.7Not reportedNot reportedNot reported
LTT462 600 mg QD1030248.8Not reportedNot reportedNot reported
LTT462 150 mg BID139058.5Not reportedNot reportedNot reported
LTT462 200 mg BID1510108.0Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        55.9
        value
        61.3
      2. group Id
        OG001
        spread
        38.8
        value
        134
      3. group Id
        OG002
        spread
        230.9
        value
        218
      4. group Id
        OG003
        spread
        126.8
        value
        494
      5. group Id
        OG004
        spread
        127.4
        value
        717
      6. group Id
        OG005
        spread
        60.8
        value
        1580
      7. group Id
        OG006
        spread
        83.5
        value
        1420
      8. group Id
        OG007
        spread
        47.7
        value
        1280
      9. group Id
        OG008
        spread
        83.0
        value
        598
      10. group Id
        OG009
        spread
        73.8
        value
        575
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        7
      6. group Id
        OG005
        value
        6
      7. group Id
        OG006
        value
        10
      8. group Id
        OG007
        value
        3
      9. group Id
        OG008
        value
        5
      10. group Id
        OG009
        value
        12
      units
      Participants
    title
    Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        29.9
        value
        139
      2. group Id
        OG001
        spread
        82.5
        value
        938
      3. group Id
        OG002
        spread
        69.0
        value
        707
      4. group Id
        OG003
        spread
        92.4
        value
        972
      5. group Id
        OG004
        spread
        131.9
        value
        1330
      6. group Id
        OG005
        spread
        83.3
        value
        2370
      7. group Id
        OG006
        spread
        49.7
        value
        3470
      8. group Id
        OG007
        spread
        248.8
        value
        1030
      9. group Id
        OG008
        spread
        58.5
        value
        1390
      10. group Id
        OG009
        spread
        108.0
        value
        1510
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        6
      6. group Id
        OG005
        value
        4
      7. group Id
        OG006
        value
        8
      8. group Id
        OG007
        value
        2
      9. group Id
        OG008
        value
        5
      10. group Id
        OG009
        value
        6
      units
      Participants
    title
    Day 15
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      8
    6. group Id
      OG005
      value
      6
    7. group Id
      OG006
      value
      11
    8. group Id
      OG007
      value
      4
    9. group Id
      OG008
      value
      6
    10. group Id
      OG009
      value
      12
    units
    Participants
description
Cmax is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration expressed in mass x volume-1.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received 45 mg LTT462 QD as oral capsules.
    id
    OG000
    title
    LTT462 45 mg QD
  2. description
    Participants received 100 mg LTT462 QD as oral capsules.
    id
    OG001
    title
    LTT462 100 mg QD
  3. description
    Participants received 150 mg LTT462 QD as oral capsules.
    id
    OG002
    title
    LTT462 150 mg QD
  4. description
    Participants received 200 mg LTT462 QD as oral capsules.
    id
    OG003
    title
    LTT462 200 mg QD
  5. description
    Participants received 300 mg LTT462 QD as oral capsules.
    id
    OG004
    title
    LTT462 300 mg QD
  6. description
    Participants received 400 mg LTT462 QD as oral capsules.
    id
    OG005
    title
    LTT462 400 mg QD
  7. description
    Participants received 450 mg LTT462 QD as oral capsules.
    id
    OG006
    title
    LTT462 450 mg QD
  8. description
    Participants received 600 mg LTT462 QD as oral capsules.
    id
    OG007
    title
    LTT462 600 mg QD
  9. description
    Participants received 150 mg LTT462 twice daily (BID) as oral capsules.
    id
    OG008
    title
    LTT462 150 mg BID
  10. description
    Participants received 200 mg LTT462 BID as oral capsules.
    id
    OG009
    title
    LTT462 200 mg BID
param Type
GEOMETRIC_MEAN
population Description
Pharmacokinetic (PK) analysis set (PAS) included of all participants who have at least 1 PK blood sample providing measurable LTT462 and received at least 1 dose of study drug, didn't vomit within 4 hours postdose, had at least 1 primary PK parameter. Here 'n' number analyzed signifies number of participants who were evaluable at each time point.
reporting Status
POSTED
time Frame
day 1, day 15
title
The Maximum (Peak) Observed Plasma, Blood, Serum, or Other Body Fluid Drug Concentration (Cmax) After Single Dose Administration of LTT462
type
SECONDARY
unit Of Measure
nanogram per milliliter (ng/mL)

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

Preserved source evidence · Not medical advice