Clinical trial NCT06181630: A Lactation Study in Women Receiving Treatment With Ozanimod
Official title: A Phase IV Postmarketing Study Evaluating Ozanimod Concentrations in the Breast Milk of Lactating Women Receiving Ozanimod Therapeutically
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Lactating Women
Breastfed Infants
Keywords: Ozanimod
BMS-986374
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-12-26
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Average concentration at steady state (Css-avg) in breast milk
timeFrame: Predose; Up to 24 hours post dose
measure: Area under the concentration-time curve over the dosing interval (AUCtau) in breast milk
timeFrame: Predose; Up to 24 hours post dose
measure: Drug daily infant dose
timeFrame: Predose; Up to 24 hours post dose
measure: Drug relative infant dose
timeFrame: Predose; Up to 24 hours post dose
Secondary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to approximately 5 months
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to approximately 5 months
measure: Number of participants with vital sign abnormalities
timeFrame: Up to approximately 5 months
measure: Number of participants with physical examination abnormalities
timeFrame: Up to approximately 5 months
measure: Plasma trough observed plasma concentration at the end of a dosing interval at steady state (Ctrough)
timeFrame: Predose; Up to 12 hours post dose
measure: Maximum observed concentration in breast milk over the dosing interval (Cmax)
timeFrame: Predose; Up to 24 hours post dose
measure: Minimum observed concentration in breast milk over the dosing interval (Cmin)
timeFrame: Predose; Up to 24 hours post dose
measure: Time to reach Cmax (Tmax)
timeFrame: Predose; Up to 24 hours post dose
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: PPD Las Vegas Clinical Research Unit
state: Nevada
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: