Trials / Withdrawn
WithdrawnNCT06181630
A Lactation Study in Women Receiving Treatment With Ozanimod
A Phase IV Postmarketing Study Evaluating Ozanimod Concentrations in the Breast Milk of Lactating Women Receiving Ozanimod Therapeutically
- Status
- Withdrawn
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the concentrations of ozanimod and its major metabolites in breast milk and the effects on breastfed infants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Breast milk, plasma, and blood samples | Although this study is non- interventional regarding treatment with ozanimod, the study is considered interventional due to the collection of breast milk and plasma from the lactating women and blood samples from their breastfed infants and the additional diagnostic and monitoring procedures required for the study. |
Timeline
- Start date
- 2025-11-15
- Primary completion
- 2026-12-16
- Completion
- 2026-12-16
- First posted
- 2023-12-26
- Last updated
- 2025-12-02
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06181630. Inclusion in this directory is not an endorsement.