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.

Study Overview

• Status: Completed
• Conditions: Focus of Study is on Healthy Lactating Women
• Intervention / Treatment: Drug: LYBALVI

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89113
      • Alkermes Investigator Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 5mg OLZAPINE /10mg SAMIDORPHAN; Open label, single dose 5mg OLZ/10 mg SAM	Drug: LYBALVI; 5 mg Olanzapine/10 mg Samidorphan dose approved for use in treatment for schizophrenia and bipolar I disorder; Other Names: ALKS 3831; Olanzapine/samidorphan (OLZ/SAM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	Time Frame
Incidence of adverse events	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
Estimated infant dose (mg/kg)	Up to 15 days
Estimated relative infant dose to the weight-adjusted maternal dose (%)	Up to 15 days

Collaborators and Investigators

• Sponsor: Alkermes, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 14, 2022
• Primary Completion (ACTUAL): November 19, 2022
• Study Completion (ACTUAL): November 19, 2022

Study Registration Dates

• First Submitted: September 16, 2022
• First Submitted That Met QC Criteria: September 16, 2022
• First Posted (ACTUAL): September 21, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Samidorphan; Breast milk; ALKS 3831; LYBALVI; Healthy Lactating Women
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Olanzapine
• Other Study ID Numbers: ALKS 3831-112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No