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NCT02269930 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy Volunteers
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT02269930 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 30 participants.
The verdict
NCT02269930, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
The primary outcome of the study is to evaluate the cumulative area under the concentration time curve (AUC) over 2 weeks, as measured by AUC from time 0 to 336 hours post dose (AUC0-336h), for serum concentrations of BIIB017 and Rebif. The secondary outcomes are to evaluate the maximum observed serum concentrations (Cmax) of BIIB017 and Rebif and to evaluate the safety and tolerability of BIIB017 and Rebif over 2 weeks in healthy volunteers.
Interventions
- DRUG peginterferon beta-1a
- DRUG Rebif
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2014-10 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02269930
The ClinicalTrials.gov registry entry for NCT02269930 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 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 2 interventions - of which peginterferon beta-1a is the first listed.
NCT02269930 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02269930 about?
NCT02269930 is a clinical study titled "Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy Volunteers". The primary outcome of the study is to evaluate the cumulative area under the concentration time curve (AUC) over 2 weeks, as measured by AUC from time 0 to 336 hours post dose (AUC0-336h), for serum concentrations of BIIB017 and Rebif. The secondary outcomes are to evaluate the maximum observed se...
What is the current status of trial NCT02269930?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2014-10. Estimated completion is 2014-12.
What interventions are being tested in trial NCT02269930?
The interventions under investigation include: peginterferon beta-1a (DRUG), Rebif (DRUG).
Who is sponsoring clinical trial NCT02269930?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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