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

This clinical lactation study is to provide information regarding the PK and amount of OLZ/SAM in breast milk and estimated infant exposure.

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