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NCT02092909 · OUTCOME

Pharmacokinetics of Escalating Dose Levels of IMO 8400 Administered by SC Injection - Cmax.

Phase 1/2 Dose Escalation Study in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia · Source last updated 2019-09-10

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

Measure
GEOMETRIC_MEAN
Unit
Cmax (ng/mL)
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1 Week 1 Day 1: Samples were obtained pre-dose (within 1 hr prior to injection) and post-dose at 1 hr (+/-5 min), 2 hrs (+/-10 min) and 4 hrs (+/-15 min)

What was measured

Pharmacokinetics of escalating dose levels of IMO 8400 administered by SC injection - Cmax.

Analysis population: PK Population

Groups in this outcome

IMO-8400 0.6 mg/kg 1x/wk

IMO-8400 0.6 mg/kg once weekly s.c.

IMO-8400 1.2 mg/kg 1x/wk

IMO-8400 1.2 mg/kg once weekly s.c.

IMO-8400 1.2 mg/kg 2x/wk

IMO-8400 1.2 mg/kg twice weekly s.c.

IMO-8400 2.4 mg/kg 1x/wk

IMO-8400 2.4 mg/kg once weekly s.c.

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

Analysis denominator · Participants

GroupSource count
IMO-8400 0.6 mg/kg 1x/wk6
IMO-8400 1.2 mg/kg 1x/wk5
IMO-8400 1.2 mg/kg 2x/wk14
IMO-8400 2.4 mg/kg 1x/wk6

Reported measurements

Source class 1
Values in Cmax (ng/mL) · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
IMO-8400 0.6 mg/kg 1x/wk807.670.3Not reportedNot reportedNot reported
IMO-8400 1.2 mg/kg 1x/wk2137.968.7Not reportedNot reportedNot reported
IMO-8400 1.2 mg/kg 2x/wk2421.250.8Not reportedNot reportedNot reported
IMO-8400 2.4 mg/kg 1x/wk4433.129.9Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        70.3
        value
        807.6
      2. group Id
        OG001
        spread
        68.7
        value
        2137.9
      3. group Id
        OG002
        spread
        50.8
        value
        2421.2
      4. group Id
        OG003
        spread
        29.9
        value
        4433.1
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      14
    4. group Id
      OG003
      value
      6
    units
    Participants
description
Pharmacokinetics of escalating dose levels of IMO 8400 administered by SC injection - Cmax.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    IMO-8400 0.6 mg/kg once weekly s.c.
    id
    OG000
    title
    IMO-8400 0.6 mg/kg 1x/wk
  2. description
    IMO-8400 1.2 mg/kg once weekly s.c.
    id
    OG001
    title
    IMO-8400 1.2 mg/kg 1x/wk
  3. description
    IMO-8400 1.2 mg/kg twice weekly s.c.
    id
    OG002
    title
    IMO-8400 1.2 mg/kg 2x/wk
  4. description
    IMO-8400 2.4 mg/kg once weekly s.c.
    id
    OG003
    title
    IMO-8400 2.4 mg/kg 1x/wk
param Type
GEOMETRIC_MEAN
population Description
PK Population
reporting Status
POSTED
time Frame
Cycle 1 Week 1 Day 1: Samples were obtained pre-dose (within 1 hr prior to injection) and post-dose at 1 hr (+/-5 min), 2 hrs (+/-10 min) and 4 hrs (+/-15 min)
title
Pharmacokinetics of Escalating Dose Levels of IMO 8400 Administered by SC Injection - Cmax.
type
SECONDARY
unit Of Measure
Cmax (ng/mL)

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

Preserved source evidence · Not medical advice