A Lactation Study in Women Receiving Treatment With Ozanimod

Bristol-Myers Squibb

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Lactating Women Breastfed Infants

Interventions

Breast milk, plasma, and blood samplesDIAGNOSTIC_TEST

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

PPD Las Vegas Clinical Research Unit

Las Vegas, Nevada, United States

Outcomes

Primary Outcomes

Average concentration at steady state (Css-avg) in breast milk

Time frame: Predose; Up to 24 hours post dose

Area under the concentration-time curve over the dosing interval (AUCtau) in breast milk

Time frame: Predose; Up to 24 hours post dose

Drug daily infant dose

Time frame: Predose; Up to 24 hours post dose

Drug relative infant dose

Time frame: Predose; Up to 24 hours post dose

Secondary Outcomes

Number of participants with adverse events (AEs)

Time frame: Up to approximately 5 months

Number of participants with clinical laboratory abnormalities

Time frame: Up to approximately 5 months

Number of participants with vital sign abnormalities

Time frame: Up to approximately 5 months

Number of participants with physical examination abnormalities

Time frame: Up to approximately 5 months

Plasma trough observed plasma concentration at the end of a dosing interval at steady state (Ctrough)

Time frame: Predose; Up to 12 hours post dose

Maximum observed concentration in breast milk over the dosing interval (Cmax)

Time frame: Predose; Up to 24 hours post dose

Minimum observed concentration in breast milk over the dosing interval (Cmin)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.