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NCT03943056 · ClinicalTrials.gov registry record · Phase 1
A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of BIIB091, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Healthy Adult Participants
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
NCT03943056 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 64 participants.
The verdict
NCT03943056, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
Study Summary
This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of BIIB091 in healthy participants.This study will also determine the effect of food on the single oral dose pharmacokinetic (PK).
Interventions
- DRUG Placebo
- DRUG BIIB091
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2019-05-13 |
| Est. Completion | 2020-01-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03943056
The ClinicalTrials.gov registry entry for NCT03943056 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 64 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.
NCT03943056 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03943056 about?
NCT03943056 is a clinical study titled "A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of BIIB091, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Healthy Adult Participants". This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of BIIB091 in healthy participants.This study will also determine the effect of food on the single oral dose pharmacokinetic (PK).
What is the current status of trial NCT03943056?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2019-05-13. Estimated completion is 2020-01-10.
What interventions are being tested in trial NCT03943056?
The interventions under investigation include: Placebo (DRUG), BIIB091 (DRUG).
Who is sponsoring clinical trial NCT03943056?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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