Trial results for a Phase 4 study (NCT06476834) evaluating deucravacitinib concentrations in the breast milk and plasma of healthy lactating female participants were posted on ClinicalTrials.gov on 2025-12-03. The study found a geometric mean maximum observed concentration (Cmax) of 211.0 ng/mL for BMS-986165 (deucravacitinib) in breast milk after a 9 mg dose.
Background
The study focused on evaluating the concentrations of deucravacitinib (BMS-986165) and its related compound (BMT-153261) in the breast milk and plasma of healthy lactating female participants. This type of pharmacokinetic study provides data to understand drug distribution in this specific population.
Trial design
The study (NCT06476834) was a Phase 4 trial designed to evaluate the pharmacokinetics of deucravacitinib. It enrolled 8 healthy lactating female participants. The intervention involved administration of deucravacitinib 9 mg, and participants were monitored for drug concentrations in breast milk and plasma. The study did not list specific primary outcome measures.
Key results
The trial measured various pharmacokinetic parameters for deucravacitinib (BMS-986165) and its related compound (BMT-153261) in breast milk following a 9 mg dose. Key results include:
- For Maximum Observed Concentration (Cmax) in Breast Milk:
- BMS-986165: Geometric mean of 211.0 ng/mL (Geometric Coefficient of Variation: 59.5).
- BMT-153261: Geometric mean of 74.09 ng/mL (Geometric Coefficient of Variation: 55.7).
- For Time of Maximum Observed Concentration (Tmax) in Breast Milk:
- BMS-986165: Median of 1.00 Hour.
- BMT-153261: Median of 6.00 Hour.
- For Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] in Breast Milk:
- BMS-986165: Geometric mean of 1656 h*ng/mL (Geometric Coefficient of Variation: 54.5).
- BMT-153261: Geometric mean of 1289 h*ng/mL (Geometric Coefficient of Variation: 58.7).
- For Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] in Breast Milk:
- BMS-986165: Geometric mean of 1876 h*ng/mL (Geometric Coefficient of Variation: 57.9).
- BMT-153261: Geometric mean of 1767 h*ng/mL (Geometric Coefficient of Variation: 61.6).
- For Average Concentration (Cavg) in Breast Milk:
- BMS-986165: Geometric mean of 78.18 ng/mL (Geometric Coefficient of Variation: 57.9).
- BMT-153261: Geometric mean of 73.61 ng/mL (Geometric Coefficient of Variation: 61.6).
- For Amount Recovered Within 24 Hours of Dosing [AR (24)] in Breast Milk:
- BMS-986165: Geometric mean of 0.05021 mg (Geometric Coefficient of Variation: 102.8).
- BMT-153261: Geometric mean of 0.03393 mg (Geometric Coefficient of Variation: 107.1).
What this means
The results from this Phase 4 pharmacokinetic study provide specific data on the concentrations of deucravacitinib and its related compound in breast milk after a single 9 mg dose. These measurements, including Cmax, Tmax, AUC, Cavg, and the total amount recovered in breast milk, are crucial for assessing the potential exposure of breastfed infants to the drug. Such data are essential for informing clinical decisions regarding the use of deucravacitinib in lactating individuals.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT06476834, titled "A Study Evaluating Deucravacitinib Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants," were posted on 2025-12-03 on clinicaltrials.gov.