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NCT04079101 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT04079101 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 31 participants.
The verdict
NCT04079101, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
The primary objective is to evaluate the pharmacokinetics (PK) of BIIB104 in healthy Japanese and non-Japanese participants. The secondary objective is to evaluate the safety and tolerability of multiple, oral doses of BIIB104 administered BID for 9 days, with an additional dose occurring in the morning on Day 10 in healthy Japanese and non-Japanese participants.
Interventions
- DRUG Placebo
- DRUG BIIB104
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2019-10-02 |
| Est. Completion | 2019-12-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04079101
The ClinicalTrials.gov registry entry for NCT04079101 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 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 Placebo is the first listed.
NCT04079101 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04079101 about?
NCT04079101 is a clinical study titled "Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants". The primary objective is to evaluate the pharmacokinetics (PK) of BIIB104 in healthy Japanese and non-Japanese participants. The secondary objective is to evaluate the safety and tolerability of multiple, oral doses of BIIB104 administered BID for 9 days, with an additional dose occurring in the mor...
What is the current status of trial NCT04079101?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2019-10-02. Estimated completion is 2019-12-27.
What interventions are being tested in trial NCT04079101?
The interventions under investigation include: Placebo (DRUG), BIIB104 (DRUG).
Who is sponsoring clinical trial NCT04079101?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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