Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan

Phase 1

Completed

• Conditions: Focus of Study is on Healthy Lactating Women
• Interventions: Drug: LYBALVI

• Registration Number: NCT05547100
• Lead Sponsor: Alkermes, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-14
• Study First Submitted: 2022-09-16
• Study First Submitted QC: 2022-09-16
• Study First Posted: 2022-09-21
• Primary Completion: 2022-11-19
• Study Completion: 2022-11-19
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
5mg OLZAPINE /10mg SAMIDORPHAN	LYBALVI	Open label, single dose 5mg OLZ/10 mg SAM

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve from time zero to 48 hours post-dose (AUC0 48)	Up to 15 days
Time to reach Cmax (tmax)	Up to 15 days
\Maximum observed concentration (Cmax)	Up to 15 days
Area under the concentration-time curve from time zero to infinity (AUC∞)	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
Terminal half-life (t½)	Up to 15 days

Secondary Outcome Measures

Name	Time	Method
Estimated relative infant dose to the weight-adjusted maternal dose (%)	Up to 15 days
Estimated infant dose (mg/kg)	Up to 15 days
Total amount of drug excreted in milk (milligrams)	Up to 15 days
Relative drug excreted in milk to dose percentage	Up to 15 days
Incidence of adverse events	Up to 15 days

Trial Locations

Locations (1)

Alkermes Investigator Site; 🇺🇸 Las Vegas, Nevada, United States