A Study Evaluating Deucravacitinib Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants

Phase 4

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Deucravacitinib

• Registration Number: NCT06476834
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to evaluate Deucravacitinib concentrations in the breast milk and plasma of healthy lactating female participants.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-21
• Study First Submitted QC: 2024-06-21
• Study Start: 2024-06-24
• Study First Posted: 2024-06-26
• Primary Completion: 2024-11-02
• Study Completion: 2024-11-02
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Deucravacitinib Administration	Deucravacitinib	-

Primary Outcome Measures

Name	Time	Method
Maximum observed milk concentration (Cmax)	Up to 72 hours
Total amount recovered in milk (AR)	Up to 72 hours
Relative infant dose of deucravacitinib	Up to 72 hours	Relative Infant Dose = Infant Dosage (mg/kg/day)/Maternal Dosage (mg/kg/day) multiplied by 100
Time of maximum observed milk concentration (Tmax)	Up to 72 hours
Area under the milk concentration-time curve from time zero extrapolated to infinite time (AUC(INF))	Up to 72 hours
Amount recovered in milk within 24 hours of dosing (AR(24))	Up to 72 hours
Area under the milk concentration-time curve from time zero to 24 hours (AUC(0-24))	Up to 72 hours
Milk-plasma ratio (M/P)	Up to 72 hours	milk AUC(0-24)/plasma AUC(0-24)
Estimated daily infant dose of deucravacitinib	Up to 72 hours	Estimated Daily Infant Dosage (mg/kg/day) = Mean M/P multiplied by the average maternal plasma concentration (Cavg) multiplied by 200 mL/kg/day
Average milk concentration (Cavg)	Up to 72 hours

Secondary Outcome Measures

Name	Time	Method
Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24))	Up to 72 hours
Number of participants with Treatment Emergent Adverse Events	Up to Day 30
Number of participants with clinical laboratory test abnormalities	Up to Day 30
Number of participants with physical examination abnormalities	Up to Day 30
Time of maximum observed plasma concentration (Tmax)	Up to 72 hours
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))	Up to 72 hours
Number of participants with vital sign abnormalities	Up to Day 30
Number of participants with electrocardiogram (ECG) abnormalities	Up to Day 30
Maximum observed plasma concentration (Cmax)	Up to 72 hours
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))	Up to 72 hours
Average plasma concentration (Cavg)	Up to 72 hours

Trial Locations

Locations (1)

Local Institution - 0001; 🇺🇸 Las Vegas, Nevada, United States