Focus of Study is on Healthy Lactating Women
Conditions
Keywords
Samidorphan, Healthy Lactating Women, LYBALVI, ALKS 3831, Breast milk
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.
Interventions
DRUGLYBALVI
5 mg Olanzapine/10 mg Samidorphan dose approved for use in treatment for schizophrenia and bipolar I disorder
Sponsors
Alkermes, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Terminal half-life (t½) | Up to 15 days |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Total amount of drug excreted in milk (milligrams) | Up to 15 days |
Countries
United States
Outcome results
None listed