Who is sponsoring NCT01500408?

NCT01500408 is sponsored by Biogen.

What condition does NCT01500408 study?

NCT01500408 studies Multiple Sclerosis.

What drugs are being tested in NCT01500408?

Interventions: Interferon beta-1a (current approved manufacturing process invloving FBS), Interferon beta-1a (new process, manufactured without FBS).

What is the status of NCT01500408?

NCT01500408 is currently COMPLETED.

Last reviewed 2012-11-16 · How we verify

A Randomized, Single-Blind, Crossover Study in Healthy Volunteers to Demonstrate the Bioequivalence of Interferon Beta-1a Manufactured by Two Different Processes

NCT01500408 Phase 1 COMPLETED

Biogen Idec has developed a novel process to manufacture Interferon beta-1a (INFB), the active ingredient of Avonex®, that does not include fetal bovine serum (FBS). This bioequivalence study is being conducted to confirm the pharmacokinetic (PK) and pharmacodynamic (PD) comparability of Interferon beta-1a produced by the currently approved serum-containing process and Interferon beta-1a produced by the new serum-free manufacturing process.

Details

Lead sponsor	Biogen
Phase	Phase 1
Status	COMPLETED
Enrolment	110
Start date	2012-01
Completion	2012-04

Conditions

Multiple Sclerosis

Interventions

Interferon beta-1a (current approved manufacturing process invloving FBS)
Interferon beta-1a (new process, manufactured without FBS)

Primary outcomes

Area under the serum concentration-time curve (AUC) as a measure of PK. — Subjects will be followed for the duration of the study, 22 days. PK samples will be taken 5 to 60 minutes prior to dosing, and post dose at hours 2, 4, 6, 9, 12, 15, 18, 21, 24, 30, 36, 48, 72, 96 and 168.

Countries

United States