A Phase IV, Open-label, Single-group, Single-dose Study Evaluating Deucravacitinib Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants

结局指标

主要结局

Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Breast Milk

时间窗: First dose day 1 to day 4 up to 72 hours

Cmax is defined as the maximum observed concentration of BMS-986165 and BMT-153261 in breast milk.

Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] of BMS-986165 and BMT-153261 in Breast Milk

时间窗: First dose day 1 up to 24 hours post dose

AUC(0-24) defined as the area under the concentration-time curve from time zero to 24 hours of BMS-986165 and BMT-153261 in breast milk.

Total Amount Recovered (AR) of BMS-986165 and BMT-153261 in Breast Milk

时间窗: First dose day 1 to day 4 up to 72 hours

AR defined as the total amount recovered of BMS-986165 and BMT-153261 in breast milk.

Average Relative Infant Dose

时间窗: First dose day 1 to day 4 up to 72 hours

Average relative infant dose shows the estimated percentage of the mother's weight-adjusted dose of study medication that the infant consumes through breast milk over a 24-hour period. This was averaged from day 1 to day 4 based on available data.

Time of Maximum Observed Concentration (Tmax) of BMS-986165 and BMT-153261 in Breast Milk

时间窗: First dose day 1 to day 4 up to 72 hours

Tmax is defined as the time taken to reach the maximum observed concentration (Cmax) of BMS-986165 and BMT-153261 in breast milk.

Amount Recovered Within 24 Hours of Dosing [AR (24)] of BMS-986165 and BMT-153261 in Breast Milk

时间窗: From first dose day 1 up to 24 hours post dose

AR (24) defined as the amount recovered within 24 hours of dosing of BMS-986165 and BMT-153261 in breast milk.

Milk-plasma Ratio (M/P) of BMS-986165 and BMT-153261

时间窗: First dose day 1 to day 4 up to 72 hours

M/P defined as milk-plasma ratio of BMS-986165 and BMT-153261.

Average Estimated Daily Infant Dose

时间窗: First dose day 1 to day 4 up to 72 hours

Average estimated daily infant dose represents the total amount of study medication that an infant is expected to consume each day average from day 1 to day 4, based on available data.

Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-986165 and BMT-153261 in Breast Milk

时间窗: First dose day 1 to day 4 up to 72 hours

AUC(INF) defined as the area under the concentration-time curve from time zero extrapolated to infinite time of BMS-986165 and BMT-153261 in breast milk.

Average Concentration (Cavg) of BMS-986165 and BMT-153261 in Breast Milk

时间窗: First dose day 1 to day 4 up to 72 hours

Cavg defined as the average concentration of BMS-986165 and BMT-153261 in breast milk.

次要结局

Average Concentration (Cavg) of BMS-986165 and BMT-153261 in Plasma(First dose day 1 to day 4 up to 72 hours)
Number of Participants With Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)(From the dose of study medication through 30 days (assessed for up to 30 days))
Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Plasma(First dose day 1 to day 4 up to 72 hours)
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-986165 and BMT-153261 in Plasma(First dose day 1 to day 4 up to 72 hours)
Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] of BMS-986165 and BMT-153261 in Plasma(First dose day 1 up to 24 hours post dose)
Time of Maximum Observed Concentration (Tmax) of BMS-986165 and BMT-153261 in Plasma(First dose day 1 to day 4 up to 72 hours)
Area Under the Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)] of BMS-986165 and BMT-153261 in Plasma(First dose day 1 to day 4 up to 72 hours)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(From the dose of study medication through 30 days (assessed for up to 30 days))
Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)(From the dose of study medication through 30 days (assessed for up to 30 days))
Number of Participants With Abnormal Physical Examinations Reported as Treatment-Emergent Adverse Events (TEAEs)(From the dose of study medication through 30 days (assessed for up to 30 days))
Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as Treatment-Emergent Adverse Events (TEAEs)(From the dose of study medication through 30 days (assessed for up to 30 days))