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This clinical lactation study is to provide information regarding the PK and amount of OLZ/SAM in breast milk and estimated infant exposure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5mg OLZAPINE /10mg SAMIDORPHAN | Experimental | Open label, single dose 5mg OLZ/10 mg SAM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LYBALVI | Drug | 5 mg Olanzapine/10 mg Samidorphan dose approved for use in treatment for schizophrenia and bipolar I disorder |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve from time zero to 48 hours post-dose (AUC0 48) | Up to 15 days | |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) | Up to 15 days | |
| Area under the concentration-time curve from time zero to infinity (AUC∞) | Up to 15 days | |
| \Maximum observed concentration (Cmax) | Up to 15 days | |
| Time to reach Cmax (tmax) | Up to 15 days | |
| Terminal half-life (t½) | Up to 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Total amount of drug excreted in milk (milligrams) | Up to 15 days | |
| Relative drug excreted in milk to dose percentage | Up to 15 days | |
| Estimated infant dose (mg/kg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sergey Yagoda, MD, PhD | Alkermes, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alkermes Investigator Site | Las Vegas | Nevada | 89113 | United States |
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| ID | Term |
|---|---|
| C000722611 | lybalvi |
| D000077152 | Olanzapine |
| C000606131 | 3-carboxamido-4-hydroxynaltrexone |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Up to 15 days |
| Estimated relative infant dose to the weight-adjusted maternal dose (%) | Up to 15 days |
| Incidence of adverse events | Up to 15 days |
| D006571 | Heterocyclic Compounds |