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NCT02757326 · OUTCOME

Maximum Concentration (Cmax) of ABC294640

ABC294640 (Opaganib) in Refractory / Relapsed Multiple Myeloma · Source last updated 2021-06-18

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

Measure
MEAN
Unit
mcg/hr/mL
Interval / dispersion
Standard Deviation
Time frame
8 hours

What was measured

To determine the Cmax of ABC294640 following administration of the drug.

Groups in this outcome

ABC294640 250 mg BID

Samples for PK were drawn on Day 1 of Cycle 1 immediately before dosing and at 1, 2, 4, and 8 hours after dosing.

ABC294640 500 mg BID

Samples for PK were drawn on Day 1 of Cycle 1 immediately before dosing and at 1, 2, 4, and 8 hours after dosing.

ABC294640 750 mg BID

Samples for PK were drawn on Day 1 of Cycle 1 immediately before dosing and at 1, 2, 4, and 8 hours after dosing.

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

Analysis denominator · Participants

GroupSource count
ABC294640 250 mg BID3
ABC294640 500 mg BID4
ABC294640 750 mg BID6

Reported measurements

Source class 1
Values in mcg/hr/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
ABC294640 250 mg BID5.61.7Not reportedNot reportedNot reported
ABC294640 500 mg BID12.52.5Not reportedNot reportedNot reported
ABC294640 750 mg BID25.83Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.7
        value
        5.6
      2. group Id
        OG001
        spread
        2.5
        value
        12.5
      3. group Id
        OG002
        spread
        3
        value
        25.8
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      6
    units
    Participants
description
To determine the Cmax of ABC294640 following administration of the drug.
dispersion Type
Standard Deviation
groups
  1. description
    Samples for PK were drawn on Day 1 of Cycle 1 immediately before dosing and at 1, 2, 4, and 8 hours after dosing.
    id
    OG000
    title
    ABC294640 250 mg BID
  2. description
    Samples for PK were drawn on Day 1 of Cycle 1 immediately before dosing and at 1, 2, 4, and 8 hours after dosing.
    id
    OG001
    title
    ABC294640 500 mg BID
  3. description
    Samples for PK were drawn on Day 1 of Cycle 1 immediately before dosing and at 1, 2, 4, and 8 hours after dosing.
    id
    OG002
    title
    ABC294640 750 mg BID
param Type
MEAN
reporting Status
POSTED
time Frame
8 hours
title
Maximum Concentration (Cmax) of ABC294640
type
SECONDARY
unit Of Measure
mcg/hr/mL

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

Preserved source evidence · Not medical advice