Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alkermes, Inc.
• Treatments: Olanzapine

Criteria

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