Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Open-Label Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan in Healthy Lactating Women

Conditions
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Focus of Study is on Healthy Lactating Women

Intervention / Treatment
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* Drug: LYBALVI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index ≥18 and <35 kg/m2 Subject is lactating, at least 4 weeks post-partum at dosing, and is using or willing to use an electronic breast pump for sample collection Subject is willing to temporarily discontinue breastfeeding for the duration of at least 11 days post-dose Subject is exclusively breastfeeding and/or pumping milk, or if not exclusively breastfeeding/pumping, has an adequate milk supply as judged by the Investigator Subject's infant is able to bottle-feed Subject agrees to use contraception during the study Exclusion Criteria: Subject has a history of lumpectomy, mastectomy, breast implants, breast augmentation, or breast reduction surgery Breastfeeding is not well-established or milk supply is low as judged by the Investigator Subject has mastitis or other condition that may prevent the collection of milk from one or both breasts Subject is pregnant or plans to become pregnant during the study Subject has had a clinically significant illness within 30 days or has had a serious infection (eg, pneumonia or septicemia) within the 3 months Subject has had any vaccination within 2 weeks prior to Screening or plans to have any vaccination during the study Subject has a history of known or suspected intolerance, allergy, or hypersensitivity to olanzapine or opioid antagonists, , or any component of the study drug (eg naltrexone, naloxone) Subject has a history of cardiovascular disease, cerebrovascular disease, a seizure disorder, personal or family history of neuroleptic malignant syndrome, or known risk of narrow-angle glaucoma or orthostatic hypotension Subject has a current or anticipated need for prescribed opioid medication during the study period Subject has a positive urine drug screen for amphetamine, barbiturates, cannabinoids, cocaine, or opioids or positive cotinine test

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5mg OLZAPINE /10mg SAMIDORPHAN<br>Open label, single dose 5mg OLZ/10 mg SAM | Drug: LYBALVI<br>* 5 mg Olanzapine/10 mg Samidorphan dose approved for use in treatment for schizophrenia and bipolar I disorder<br>* Other names: ALKS 3831;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Samidorphan, Healthy Lactating Women, LYBALVI, ALKS 3831, Breast milk