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NCT00675428 · OUTCOME

Pharmacokinetic (PK) Profile Of Natalizumab

Study of Natalizumab in Relapsed/Refractory Multiple Myeloma · Source last updated 2014-09-19

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

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Cycles 1 and 6: Day 1 (before infusion and 0.25, 2, 6 and 24 hours after infusion), Days 8, 15, 22. Cycles 2-5: Day 1 (before infusion and 0.25 hour after infusion)

What was measured

PK modeling, either compartmental or noncompartmental-based, was used to describe serum concentrations. Standard PK parameters estimated include: area-under-the-concentration-time curve (AUC), maximum-observed concentration (Cmax), time-to-reach maximum concentration (Tmax), total body clearance (Cl), volume of distribution (Vd), and elimination half-life (t1/2).

Analysis population: PK analysis was not performed because the study was terminated early.

Groups in this outcome

Natalizumab 300 mg

Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.

Natalizumab 450 mg

Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.

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

Analysis denominator · Participants

GroupSource count
Natalizumab 300 mg0
Natalizumab 450 mg0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    units
    Participants
description
PK modeling, either compartmental or noncompartmental-based, was used to describe serum concentrations. Standard PK parameters estimated include: area-under-the-concentration-time curve (AUC), maximum-observed concentration (Cmax), time-to-reach maximum concentration (Tmax), total body clearance (Cl), volume of distribution (Vd), and elimination half-life (t1/2).
groups
  1. description
    Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
    id
    OG000
    title
    Natalizumab 300 mg
  2. description
    Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
    id
    OG001
    title
    Natalizumab 450 mg
population Description
PK analysis was not performed because the study was terminated early.
reporting Status
POSTED
time Frame
Cycles 1 and 6: Day 1 (before infusion and 0.25, 2, 6 and 24 hours after infusion), Days 8, 15, 22. Cycles 2-5: Day 1 (before infusion and 0.25 hour after infusion)
title
Pharmacokinetic (PK) Profile Of Natalizumab
type
SECONDARY

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

Preserved source evidence · Not medical advice