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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 is a Phase 1 study that has completed, run by Alkermes. The registered enrollment target is 7 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04987658
The ClinicalTrials.gov registry entry for NCT04987658 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alkermes, which has 66 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which OLZ/SAM is the first listed.
NCT04987658 reports 0 study locations.
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.
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