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NCT00552396 · OUTCOME

Maximum Plasma Concentration (Cmax) of IPH2101 After Cycle 1 Administration

An Open-label, Dose-escalation Safety and Tolerability Trial Assessing Anti-KIR (1-7F9) in Subjects With Multiple Myeloma · Source last updated 2016-03-31

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

Measure
GEOMETRIC_MEAN
Unit
ng/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Anti-KIR (1-7F9) concentrations were measured prior to infusion at 0.167, 1, 3, 6, 12 and 24 hours and then on Days 7, 14 and 21 after the start of the first dose administration

What was measured

Cmax was obtained from the plasma concentration versus time data after IV administration of IPH2101.

Groups in this outcome

IPH2101 0.0003 mg/kg

IV Bolus

IPH2101 0.003 mg/kg

IV Bolus

IPH2101 0.015 mg/kg

IV Bolus

IPH2101 0.075 mg/kg

IV 1 hour infusion

IPH2101 0.3 mg/kg

IV 1 hour infusion

IPH2101 1 mg/kg

IV 1 hour infusion

IPH2101 3 mg/kg

IV 1 hour infusion

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

Analysis denominator · Participants

GroupSource count
IPH2101 0.0003 mg/kg2
IPH2101 0.003 mg/kg3
IPH2101 0.015 mg/kg3
IPH2101 0.075 mg/kg6
IPH2101 0.3 mg/kg3
IPH2101 1 mg/kg3
IPH2101 3 mg/kg10

Reported measurements

Source class 1
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
IPH2101 0.0003 mg/kg00Not reportedNot reportedNot reported
IPH2101 0.003 mg/kg45.841.3Not reportedNot reportedNot reported
IPH2101 0.015 mg/kg31653.8Not reportedNot reportedNot reported
IPH2101 0.075 mg/kg162038.4Not reportedNot reportedNot reported
IPH2101 0.3 mg/kg451030.9Not reportedNot reportedNot reported
IPH2101 1 mg/kg2480025.5Not reportedNot reportedNot reported
IPH2101 3 mg/kg5520031.7Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0
        value
        0
      2. group Id
        OG001
        spread
        41.3
        value
        45.8
      3. group Id
        OG002
        spread
        53.8
        value
        316
      4. group Id
        OG003
        spread
        38.4
        value
        1620
      5. group Id
        OG004
        spread
        30.9
        value
        4510
      6. group Id
        OG005
        spread
        25.5
        value
        24800
      7. group Id
        OG006
        spread
        31.7
        value
        55200
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      6
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      3
    7. group Id
      OG006
      value
      10
    units
    Participants
description
Cmax was obtained from the plasma concentration versus time data after IV administration of IPH2101.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    IV Bolus
    id
    OG000
    title
    IPH2101 0.0003 mg/kg
  2. description
    IV Bolus
    id
    OG001
    title
    IPH2101 0.003 mg/kg
  3. description
    IV Bolus
    id
    OG002
    title
    IPH2101 0.015 mg/kg
  4. description
    IV 1 hour infusion
    id
    OG003
    title
    IPH2101 0.075 mg/kg
  5. description
    IV 1 hour infusion
    id
    OG004
    title
    IPH2101 0.3 mg/kg
  6. description
    IV 1 hour infusion
    id
    OG005
    title
    IPH2101 1 mg/kg
  7. description
    IV 1 hour infusion
    id
    OG006
    title
    IPH2101 3 mg/kg
param Type
GEOMETRIC_MEAN
reporting Status
POSTED
time Frame
Anti-KIR (1-7F9) concentrations were measured prior to infusion at 0.167, 1, 3, 6, 12 and 24 hours and then on Days 7, 14 and 21 after the start of the first dose administration
title
Maximum Plasma Concentration (Cmax) of IPH2101 After Cycle 1 Administration
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice