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NCT02711345 · OUTCOME

Elimination Half-life (T1/2) 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
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

T1/2 is the Elimination half-life.

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 QD1
LTT462 100 mg QD2
LTT462 150 mg QD4
LTT462 200 mg QD2
LTT462 300 mg QD3
LTT462 400 mg QD6
LTT462 450 mg QD7
LTT462 600 mg QD2
LTT462 150 mg BID2
LTT462 200 mg BID9

Reported measurements

Source class 1
Values in hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
LTT462 45 mg QD27.9Not reported27.927.9Not reported
LTT462 100 mg QD39.2Not reported28.849.5Not reported
LTT462 150 mg QD20.8Not reported13.424.5Not reported
LTT462 200 mg QD16.8Not reported16.716.8Not reported
LTT462 300 mg QD15.2Not reported14.919.6Not reported
LTT462 400 mg QD14.0Not reported12.018.7Not reported
LTT462 450 mg QD17.6Not reported16.118.9Not reported
LTT462 600 mg QD13.2Not reported11.814.5Not reported
LTT462 150 mg BID16.2Not reported13.319.1Not reported
LTT462 200 mg BID17.1Not reported11.641.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        27.9
        upper Limit
        27.9
        value
        27.9
      2. group Id
        OG001
        lower Limit
        28.8
        upper Limit
        49.5
        value
        39.2
      3. group Id
        OG002
        lower Limit
        13.4
        upper Limit
        24.5
        value
        20.8
      4. group Id
        OG003
        lower Limit
        16.7
        upper Limit
        16.8
        value
        16.8
      5. group Id
        OG004
        lower Limit
        14.9
        upper Limit
        19.6
        value
        15.2
      6. group Id
        OG005
        lower Limit
        12.0
        upper Limit
        18.7
        value
        14.0
      7. group Id
        OG006
        lower Limit
        16.1
        upper Limit
        18.9
        value
        17.6
      8. group Id
        OG007
        lower Limit
        11.8
        upper Limit
        14.5
        value
        13.2
      9. group Id
        OG008
        lower Limit
        13.3
        upper Limit
        19.1
        value
        16.2
      10. group Id
        OG009
        lower Limit
        11.6
        upper Limit
        41.1
        value
        17.1
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      2
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      6
    7. group Id
      OG006
      value
      7
    8. group Id
      OG007
      value
      2
    9. group Id
      OG008
      value
      2
    10. group Id
      OG009
      value
      9
    units
    Participants
description
T1/2 is the Elimination half-life.
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 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
Elimination Half-life (T1/2) of LTT462
type
SECONDARY
unit Of Measure
hour

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

Preserved source evidence · Not medical advice