Breastfed Infants, Lactating Women
Conditions
Keywords
Ozanimod, BMS-986374
Brief 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.
Interventions
DIAGNOSTIC_TESTBreast 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.
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult female participant is already planning or currently being treated with ozanimod per the current locally approved prescribing information. * Adult female participant has delivered a single normal-term infant (at least 37 weeks gestation). * Adult female participant is at least 2 weeks postpartum but not more than 12 months postpartum by Study Visit 1. * Infant participant has normal weight for gestational age (above tenth percentile) at birth.
Exclusion criteria
* Adult participant is pregnant, planning to become pregnant, or are of childbearing potential and not using an effective contraceptive method. * Adult participant is not breastfeeding or pumping milk. * Adult participant has received any live vaccinations within 4 weeks prior to the start of ozanimod treatment. * Infant participant was born less than 37 weeks gestation Other protocol-defined criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average concentration at steady state (Css-avg) in breast milk | Predose; Up to 24 hours post dose |
| Area under the concentration-time curve over the dosing interval (AUCtau) in breast milk | Predose; Up to 24 hours post dose |
| Drug daily infant dose | Predose; Up to 24 hours post dose |
| Drug relative infant dose | Predose; Up to 24 hours post dose |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with physical examination abnormalities | Up to approximately 5 months |
| Maximum observed concentration in breast milk over the dosing interval (Cmax) | Predose; Up to 24 hours post dose |
| Plasma trough observed plasma concentration at the end of a dosing interval at steady state (Ctrough) | Predose; Up to 12 hours post dose |
| Time to reach Cmax (Tmax) | Predose; Up to 24 hours post dose |
| Minimum observed concentration in breast milk over the dosing interval (Cmin) | Predose; Up to 24 hours post dose |
| Number of participants with adverse events (AEs) | Up to approximately 5 months |
| Number of participants with clinical laboratory abnormalities | Up to approximately 5 months |
| Number of participants with vital sign abnormalities | Up to approximately 5 months |
Countries
United States
Outcome results
None listed