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NCT05655507 · ClinicalTrials.gov registry record · Phase 1
Zuranolone Pharmacokinetics (PK) and Safety Study Adolescent Participants With Major Depressive Disorder (MDD)
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT05655507: Completed Phase 1 study, sponsored by Biogen.
NCT05655507 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05655507, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
The primary purpose of this study is to evaluate the pharmacokinetics and safety of Zuranolone in adolescents (ages 12 to 17 years) with MDD.
Primary Outcome
PK Parameters of Zuranolone will be assessed.
Interventions
- DRUG Zuranolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2023-04-19 |
| Est. Completion | 2024-10-18 |
| Phase | Phase 1 |
What the finished NCT05655507 record still lists
NCT05655507 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 1 intervention - of which Zuranolone is the first listed.
NCT05655507 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05655507 about?
NCT05655507 is a clinical study titled "Zuranolone Pharmacokinetics (PK) and Safety Study Adolescent Participants With Major Depressive Disorder (MDD)". The primary purpose of this study is to evaluate the pharmacokinetics and safety of Zuranolone in adolescents (ages 12 to 17 years) with MDD.
What is the current status of trial NCT05655507?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2023-04-19. Estimated completion is 2024-10-18.
What interventions are being tested in trial NCT05655507?
The interventions under investigation include: Zuranolone (DRUG).
Who is sponsoring clinical trial NCT05655507?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05655507's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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