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NCT02711345 · OUTCOME

The Time to Reach Maximum (Peak) Plasma, Blood, Serum, or Other Body Fluid Drug Concentration (Tmax) 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
MEDIAN
Unit
hour
Interval / dispersion
Full Range
Time frame
day 1, day 15

What was measured

Tmax is the time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration.

Analysis population: 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 hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
LTT462 45 mg QD2.45Not reported0.9673.93Not reported
LTT462 100 mg QD1.98Not reported0.86724.0Not reported
LTT462 150 mg QD3.49Not reported2.0024.3Not reported
LTT462 200 mg QD5.48Not reported3.0046.4Not reported
LTT462 300 mg QD3.08Not reported2.0848.8Not reported
LTT462 400 mg QD3.04Not reported1.124.00Not reported
LTT462 450 mg QD3.98Not reported2.427.77Not reported
LTT462 600 mg QD3.95Not reported2.004.20Not reported
LTT462 150 mg BID2.25Not reported2.0049.8Not reported
LTT462 200 mg BID3.03Not reported0.4677.78Not 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 hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
LTT462 45 mg QD5.93Not reported4.007.85Not reported
LTT462 100 mg QD4.02Not reported1.004.83Not reported
LTT462 150 mg QD4.05Not reported2.138.00Not reported
LTT462 200 mg QD3.00Not reported2.173.02Not reported
LTT462 300 mg QD2.59Not reported1.584.03Not reported
LTT462 400 mg QD2.55Not reported1.873.15Not reported
LTT462 450 mg QD2.98Not reported1.007.62Not reported
LTT462 600 mg QD5.25Not reported3.007.50Not reported
LTT462 150 mg BID2.17Not reported2.053.15Not reported
LTT462 200 mg BID2.18Not reported2.004.15Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.967
        upper Limit
        3.93
        value
        2.45
      2. group Id
        OG001
        lower Limit
        0.867
        upper Limit
        24.0
        value
        1.98
      3. group Id
        OG002
        lower Limit
        2.00
        upper Limit
        24.3
        value
        3.49
      4. group Id
        OG003
        lower Limit
        3.00
        upper Limit
        46.4
        value
        5.48
      5. group Id
        OG004
        lower Limit
        2.08
        upper Limit
        48.8
        value
        3.08
      6. group Id
        OG005
        lower Limit
        1.12
        upper Limit
        4.00
        value
        3.04
      7. group Id
        OG006
        lower Limit
        2.42
        upper Limit
        7.77
        value
        3.98
      8. group Id
        OG007
        lower Limit
        2.00
        upper Limit
        4.20
        value
        3.95
      9. group Id
        OG008
        lower Limit
        2.00
        upper Limit
        49.8
        value
        2.25
      10. group Id
        OG009
        lower Limit
        0.467
        upper Limit
        7.78
        value
        3.03
    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
        lower Limit
        4.00
        upper Limit
        7.85
        value
        5.93
      2. group Id
        OG001
        lower Limit
        1.00
        upper Limit
        4.83
        value
        4.02
      3. group Id
        OG002
        lower Limit
        2.13
        upper Limit
        8.00
        value
        4.05
      4. group Id
        OG003
        lower Limit
        2.17
        upper Limit
        3.02
        value
        3.00
      5. group Id
        OG004
        lower Limit
        1.58
        upper Limit
        4.03
        value
        2.59
      6. group Id
        OG005
        lower Limit
        1.87
        upper Limit
        3.15
        value
        2.55
      7. group Id
        OG006
        lower Limit
        1.00
        upper Limit
        7.62
        value
        2.98
      8. group Id
        OG007
        lower Limit
        3.00
        upper Limit
        7.50
        value
        5.25
      9. group Id
        OG008
        lower Limit
        2.05
        upper Limit
        3.15
        value
        2.17
      10. group Id
        OG009
        lower Limit
        2.00
        upper Limit
        4.15
        value
        2.18
    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
Tmax is the time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration.
dispersion Type
Full Range
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
MEDIAN
population Description
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 Time to Reach Maximum (Peak) Plasma, Blood, Serum, or Other Body Fluid Drug Concentration (Tmax) After Single Dose Administration of LTT462
type
SECONDARY
unit Of Measure
hour

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Preserved source evidence · Not medical advice