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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 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. The trial reports 1 study location across 1 state.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05547100
The ClinicalTrials.gov registry entry for NCT05547100 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 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 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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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