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NCT02711345 · OUTCOME

Area Under the Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) 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
hour*nanogram per milliliter (h*ng/mL)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1 Days 1, 2, 3, 8, 15 and 16; Cycle 2 day 1 and 15; Cycle 3 Day 1; Cycle 5 Day 1

What was measured

AUClast is the area under the curve from time zero to the last measurable concentration sampling time calculated by mass \* time \*volume\^-1

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 of participants analyzed signifies number of participants who were evaluable for this outcome measure.

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 QD7
LTT462 400 mg QD6
LTT462 450 mg QD10
LTT462 600 mg QD3
LTT462 150 mg BID5
LTT462 200 mg BID12

Reported measurements

Source class 1
Values in hour*nanogram per milliliter (h*ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
LTT462 45 mg QD851106.0Not reportedNot reportedNot reported
LTT462 100 mg QD226030.0Not reportedNot reportedNot reported
LTT462 150 mg QD3880133.6Not reportedNot reportedNot reported
LTT462 200 mg QD1040095.4Not reportedNot reportedNot reported
LTT462 300 mg QD12800157.4Not reportedNot reportedNot reported
LTT462 400 mg QD2330055.5Not reportedNot reportedNot reported
LTT462 450 mg QD23800115.3Not reportedNot reportedNot reported
LTT462 600 mg QD1180064.2Not reportedNot reportedNot reported
LTT462 150 mg BID924078.3Not reportedNot reportedNot reported
LTT462 200 mg BID763098.8Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        106.0
        value
        851
      2. group Id
        OG001
        spread
        30.0
        value
        2260
      3. group Id
        OG002
        spread
        133.6
        value
        3880
      4. group Id
        OG003
        spread
        95.4
        value
        10400
      5. group Id
        OG004
        spread
        157.4
        value
        12800
      6. group Id
        OG005
        spread
        55.5
        value
        23300
      7. group Id
        OG006
        spread
        115.3
        value
        23800
      8. group Id
        OG007
        spread
        64.2
        value
        11800
      9. group Id
        OG008
        spread
        78.3
        value
        9240
      10. group Id
        OG009
        spread
        98.8
        value
        7630
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
description
AUClast is the area under the curve from time zero to the last measurable concentration sampling time calculated by mass \* time \*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
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 of participants analyzed signifies number of participants who were evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Cycle 1 Days 1, 2, 3, 8, 15 and 16; Cycle 2 day 1 and 15; Cycle 3 Day 1; Cycle 5 Day 1
title
Area Under the Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) of LTT462
type
SECONDARY
unit Of Measure
hour*nanogram per milliliter (h*ng/mL)

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Preserved source evidence · Not medical advice