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NCT04987658 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder
A Phase 1 study, sponsored by Alkermes.
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT04987658: Completed Phase 1 study, sponsored by Alkermes.
NCT04987658 is a Phase 1 study that has completed, run by Alkermes. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04987658, a Phase 1 study, has completed, sponsored by Alkermes.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
To evaluate the safety, tolerability, and pharmacokinetics of olanzapine and samidorphan in clinically stable pediatric subjects (10 to 12 years old) with Bipolar I disorder following oral administration of multiple ascending doses of OLZ/SAM
Interventions
- DRUG OLZ/SAM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2021-07-22 |
| Est. Completion | 2023-08-11 |
| Phase | Phase 1 |
What the finished NCT04987658 record still lists
NCT04987658 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which OLZ/SAM is the first listed.
NCT04987658 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04987658 about?
NCT04987658 is a clinical study titled "Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder". To evaluate the safety, tolerability, and pharmacokinetics of olanzapine and samidorphan in clinically stable pediatric subjects (10 to 12 years old) with Bipolar I disorder following oral administration of multiple ascending doses of OLZ/SAM
What is the current status of trial NCT04987658?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2021-07-22. Estimated completion is 2023-08-11.
What interventions are being tested in trial NCT04987658?
The interventions under investigation include: OLZ/SAM (DRUG).
Who is sponsoring clinical trial NCT04987658?
This trial is sponsored by Alkermes, which has 66 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04987658's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 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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