A Pharmacokinetic (PK) Study of Natalizumab (Tysabri) at Steady State
|ClinicalTrials.gov Identifier: NCT00744679|
Recruitment Status : Completed
First Posted : September 1, 2008
Last Update Posted : February 10, 2015
The primary objective is to assess the pharmacokinetic (PK) profile of natalizumab (Tysabri) at steady state.
The secondary objective is to assess the pharmacodynamics (PD) profile (α4 integrin saturation) of Tysabri at steady state.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: Natalizumab||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||An Assessment of the Steady-State Pharmacokinetic and Pharmacodynamic Profile of Tysabri 300 mg Following at Least 12 Monthly Infusions|
|Study Start Date :||November 2008|
|Primary Completion Date :||December 2008|
|Study Completion Date :||December 2008|
Experimental: Natalizumab 300 mg
Natalizumab infused at 300 mg every 28 days during the screening and assessment periods of the study which continues the therapy of the previous 12 months and maintains steady-state pharmacokinetics.
Participants continue to receive regularly-scheduled doses of Tysabri (300 mg infusion every 28±7 days) through the Tysabri Outreach: United Commitment to Health Prescribing Program (TOUCH) throughout the screening and assessment periods. Participants must continue to be dosed every 28±7 days in order to maintain steady-state pharmacokinetics.
- Pharmacokinetic (PK) Profile of Natalizumab [ Time Frame: Baseline (Day 0), 2 hours after infusion starts on Days 1 and on Days 2, 3, 4, 7, 14, 21 and 28 ]
- Natalizumab Binding Saturation Of α4 Integrin Sites On Peripheral Blood Mononuclear Cells (PBMC). [ Time Frame: Baseline (Day 0), 2 Hours after infusion starts on Days 1, and on Days 4, 7, 14, 21 and 28 ]The pharmacodynamic activity of natalizumab is assessed by measuring the degree of natalizumab saturation of the VLA-4 (α4β1 integrin) receptor on peripheral blood lymphocyte/monocyte populations.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00744679
|United States, New York|
|Latham, New York, United States|
|Study Director:||Medical Director||Biogen|