Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01462318 · ClinicalTrials.gov registry record · Phase 3
An Open-Label Immunogenicity and Pharmacokinetics Study of Daclizumab High Yield Process Prefilled Syringe in Relapsing Remitting Multiple Sclerosis
A Phase 3 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 3
- Development phase
- 133
- Enrollment target
NCT01462318 is a Phase 3 study that has completed, run by Biogen. The registered enrollment target is 133 participants.
The verdict
NCT01462318, a Phase 3 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 133 participants
- Enrollment target
Study Summary
The primary objective of the study is to assess the immunogenicity of Daclizumab High Yield Process (DAC HYP) 150 mg administered every 4 weeks by subcutaneous (SC) injection using the pre-filled syringe (PFS) in participants with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of this study are to characterize the pharmacokinetics (PK) of DAC HYP following single and multiple doses of DAC HYP administered by the PFS in a subset of participants with RRMS and to evaluate the effect of DAC HYP on the PK of probe drugs for cytochrome P450 (CYP) isoenzymes (CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A).
Interventions
- DRUG Midazolam
- DRUG Omeprazole
- OTHER Caffeine
- DRUG S-warfarin
- OTHER Vitamin K
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 133 participants |
| Start Date | 2011-11 |
| Est. Completion | 2016-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01462318
The ClinicalTrials.gov registry entry for NCT01462318 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 133 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Midazolam is the first listed.
NCT01462318 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01462318 about?
NCT01462318 is a clinical study titled "An Open-Label Immunogenicity and Pharmacokinetics Study of Daclizumab High Yield Process Prefilled Syringe in Relapsing Remitting Multiple Sclerosis". The primary objective of the study is to assess the immunogenicity of Daclizumab High Yield Process (DAC HYP) 150 mg administered every 4 weeks by subcutaneous (SC) injection using the pre-filled syringe (PFS) in participants with relapsing-remitting multiple sclerosis (RRMS). The secondary objectiv...
What is the current status of trial NCT01462318?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 133 participants. The study started on 2011-11. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01462318?
The interventions under investigation include: Midazolam (DRUG), Omeprazole (DRUG), Caffeine (OTHER), S-warfarin (DRUG), Vitamin K (OTHER).
Who is sponsoring clinical trial NCT01462318?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.