Clinical trial NCT05547100: Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan
Official title: A Phase 1, Open-Label Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan in Healthy Lactating Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Focus of Study is on Healthy Lactating Women
Keywords: Samidorphan
Healthy Lactating Women
LYBALVI
ALKS 3831
Breast milk
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2022-09-21
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Area under the concentration-time curve from time zero to 48 hours post-dose (AUC0 48)
timeFrame: Up to 15 days
measure: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
timeFrame: Up to 15 days
measure: Area under the concentration-time curve from time zero to infinity (AUC∞)
timeFrame: Up to 15 days
measure: \Maximum observed concentration (Cmax)
timeFrame: Up to 15 days
measure: Time to reach Cmax (tmax)
timeFrame: Up to 15 days
measure: Terminal half-life (t½)
timeFrame: Up to 15 days
Secondary outcomes:
measure: Total amount of drug excreted in milk (milligrams)
timeFrame: Up to 15 days
measure: Relative drug excreted in milk to dose percentage
timeFrame: Up to 15 days
measure: Estimated infant dose (mg/kg)
timeFrame: Up to 15 days
measure: Estimated relative infant dose to the weight-adjusted maternal dose (%)
timeFrame: Up to 15 days
measure: Incidence of adverse events
timeFrame: Up to 15 days
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Alkermes Investigator Site
state: Nevada
Study officials:
affiliation: Alkermes, Inc.
name: Sergey Yagoda, MD, PhD
role: STUDY_DIRECTOR
References: