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NCT05547100 · ClinicalTrials.gov registry record · Phase 1
Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan
A Phase 1 study of Focus of Study is on Healthy Lactating Women, sponsored by Alkermes.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT05547100: Completed Phase 1 study of Focus of Study is on Healthy Lactating Women, sponsored by Alkermes.
NCT05547100 is a Phase 1 study of Focus of Study is on Healthy Lactating Women that has completed, run by Alkermes. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05547100, a Phase 1 study of Focus of Study is on Healthy Lactating Women, has completed, sponsored by Alkermes.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This clinical lactation study is to provide information regarding the PK and amount of OLZ/SAM in breast milk and estimated infant exposure.
Conditions Studied
Interventions
- DRUG LYBALVI
Study Locations (1)
Nevada
- Alkermes Investigator Site - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-09-14 |
| Est. Completion | 2022-11-19 |
| Phase | Phase 1 |
What the finished NCT05547100 record still lists
NCT05547100 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Focus of Study is on Healthy Lactating Women appearing as the primary indexed condition, and to 1 intervention - of which LYBALVI is the first listed.
NCT05547100 reports a single indexed study location in Nevada.
Frequently Asked Questions
What is clinical trial NCT05547100 about?
NCT05547100 is a clinical study titled "Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan". This clinical lactation study is to provide information regarding the PK and amount of OLZ/SAM in breast milk and estimated infant exposure.
What is the current status of trial NCT05547100?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2022-09-14. Estimated completion is 2022-11-19.
What conditions does trial NCT05547100 study?
This clinical trial studies the following conditions: Focus of Study is on Healthy Lactating Women.
What interventions are being tested in trial NCT05547100?
The interventions under investigation include: LYBALVI (DRUG).
Who is sponsoring clinical trial NCT05547100?
This trial is sponsored by Alkermes, which has 66 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05547100 being conducted?
This trial has 1 study location across Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05547100's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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