Trials / Completed
CompletedNCT00744679
A Pharmacokinetic (PK) Study of Natalizumab (Tysabri) at Steady State
An Assessment of the Steady-State Pharmacokinetic and Pharmacodynamic Profile of Tysabri 300 mg Following at Least 12 Monthly Infusions
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Natalizumab | 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. |
Timeline
- Start date
- 2008-11-01
- Primary completion
- 2008-12-01
- Completion
- 2008-12-01
- First posted
- 2008-09-01
- Last updated
- 2015-02-10
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00744679. Inclusion in this directory is not an endorsement.