Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan

NCT ID: NCT05547100

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-14
• Study Completion Date: 2022-11-19

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.

Conditions

Focus of Study is on Healthy Lactating Women

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

5mg OLZAPINE /10mg SAMIDORPHAN

Open label, single dose 5mg OLZ/10 mg SAM

Group Type: EXPERIMENTAL

LYBALVI

Intervention Type: DRUG

5 mg Olanzapine/10 mg Samidorphan dose approved for use in treatment for schizophrenia and bipolar I disorder

Interventions

LYBALVI

5 mg Olanzapine/10 mg Samidorphan dose approved for use in treatment for schizophrenia and bipolar I disorder

Intervention Type: DRUG

Other Intervention Names

Olanzapine/samidorphan (OLZ/SAM); ALKS 3831

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Alkermes, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sergey Yagoda, MD, PhD

Role: STUDY_DIRECTOR

Alkermes, Inc.

Locations

Alkermes Investigator Site

Las Vegas, Nevada, United States

Countries

United States

Other Identifiers

ALKS 3831-112

Identifier Type: -

Identifier Source: org_study_id