Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan

NCT05547100 | Completed Phase 1 FDA Drug

• 1 other identifier: ALKS 3831-112
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

Samidorphan; Healthy Lactating Women; LYBALVI; ALKS 3831; Breast milk

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• 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

• Incidence of adverse events

  Up to 15 days

Study Arms (1)

5mg OLZAPINE /10mg SAMIDORPHAN

EXPERIMENTAL

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

Drug: LYBALVI

Interventions

LYBALVI DRUG

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

Also known as: Olanzapine/samidorphan (OLZ/SAM), ALKS 3831

5mg OLZAPINE /10mg SAMIDORPHAN

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alkermes, Inc.: lead

Study Sites (1)

Alkermes Investigator Site

Las Vegas, Nevada, 89113, United States

Location

MeSH Terms

Interventions

lybalvi; Olanzapine; 3-carboxamido-4-hydroxynaltrexone

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sergey Yagoda, MD, PhD

  Alkermes, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: September 21, 2022
• Study Start: September 14, 2022
• Primary Completion: November 19, 2022
• Study Completion: November 19, 2022
• Last Updated: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)