Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

September 14, 2022

Primary Completion Date

November 19, 2022

Study Completion Date

November 19, 2022

Conditions
Focus of Study is on Healthy Lactating Women
Interventions
DRUG

LYBALVI

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

Trial Locations (1)

89113

Alkermes Investigator Site, Las Vegas

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Alkermes, Inc.

INDUSTRY