Trials / Completed
CompletedNCT05547100
Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan
A Phase 1, Open-Label Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan in Healthy Lactating Women
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Alkermes, Inc. · Industry
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LYBALVI | 5 mg Olanzapine/10 mg Samidorphan dose approved for use in treatment for schizophrenia and bipolar I disorder |
Timeline
- Start date
- 2022-09-14
- Primary completion
- 2022-11-19
- Completion
- 2022-11-19
- First posted
- 2022-09-21
- Last updated
- 2023-02-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05547100. Inclusion in this directory is not an endorsement.