drugset
drugset / Trial / NCT05547100

Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan

NCT05547100 ↗

Phase 1 Completed 12 enrolled Alkermes, Inc.
NaSingle-groupOpen-labelTreatment

Summary

This clinical lactation study is to provide information regarding the PK and amount of OLZ/SAM in breast milk and estimated infant exposure.

Timeline

Start
2022-09-14
Primary completion
2022-11-19
Completion
2022-11-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Olanzapine Small molecule 5 mg —
Subject Samidorphan Small molecule 10 mg —

Indications

No indication recorded.