Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan

Alkermes

Status and phase

Completed

Phase 1

Conditions

Focus of Study is on Healthy Lactating Women

Treatments

Drug: LYBALVI

Study type

Interventional

Funder types

Industry

Identifiers

ALKS 3831-112

Details and patient eligibility

About

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

Enrollment

12 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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