Phase 4
N=8
A Study Evaluating Deucravacitinib Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT06476834 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Breast Milk — 211.0; 74.09 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Deucravacitinib (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Breast Milk |
211.0; 74.09 | — |
| PRIMARY Time of Maximum Observed Concentration (Tmax) of BMS-986165 and BMT-153261 in Breast Milk |
1.00; 6.00 | — |
| PRIMARY Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] of BMS-986165 and BMT-153261 in Breast Milk |
1656; 1289 | — |
| PRIMARY Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-986165 and BMT-153261 in Breast Milk |
1876; 1767 | — |
| PRIMARY Average Concentration (Cavg) of BMS-986165 and BMT-153261 in Breast Milk |
78.18; 73.61 | — |
| PRIMARY Amount Recovered Within 24 Hours of Dosing [AR (24)] of BMS-986165 and BMT-153261 in Breast Milk |
0.05021; 0.03393 | — |
| PRIMARY Total Amount Recovered (AR) of BMS-986165 and BMT-153261 in Breast Milk |
0.05395; 0.04230 | — |
| PRIMARY Milk-plasma Ratio (M/P) of BMS-986165 and BMT-153261 |
3.241; 15.76 | — |
| PRIMARY Average Estimated Daily Infant Dose |
0.01586 | — |
| PRIMARY Average Relative Infant Dose |
12.11 | — |
| SECONDARY Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Plasma |
62.56; 4.797 | — |
| SECONDARY Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-986165 and BMT-153261 in Plasma |
587.2; 128.3 | — |
| SECONDARY Area Under the Concentration-time Curve From Time Zero to 24 Hours [AUC(0-24)] of BMS-986165 and BMT-153261 in Plasma |
511.0; 81.79 | — |
| SECONDARY 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 |
575.1; 104.5 | — |
| SECONDARY Time of Maximum Observed Concentration (Tmax) of BMS-986165 and BMT-153261 in Plasma |
2.00; 6.00 | — |
| SECONDARY Average Concentration (Cavg) of BMS-986165 and BMT-153261 in Plasma |
24.47; 5.346 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
— | — |
| SECONDARY Number of Participants With Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) |
— | — |
| SECONDARY Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) |
— | — |
| SECONDARY Number of Participants With Abnormal Physical Examinations Reported as Treatment-Emergent Adverse Events (TEAEs) |
— | — |
| SECONDARY Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as Treatment-Emergent Adverse Events (TEAEs) |
— | — |
Summary
The purpose of this study is to evaluate Deucravacitinib concentrations in the breast milk and plasma of healthy lactating female participants.
Eligibility Criteria
Inclusion Criteria
- Healthy female participants without, in the opinion of the investigator, clinically significant deviation from normal in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations.
- Body mass index (BMI) of 18.0 kg/m2 to 35.0 kg/m2, inclusive, and body weight ≥ 50 kg (110 lb), at screening. Given participants are postpartum, BMI accommodation up to 35.0 kg/m2 may be expected.
- Has well-established lactation (ie, at least 4 weeks postpartum) and can produce stable milk product (ie, approximately 3 oz per 3 hours at screening) using the methods required for the study.
- Is willing to exclusively pump breast milk for the 72-hour post dose period of milk collection during CRU confinement, and not to breastfeed or provide milk to infant until after CRU discharge (72 hours post dose).
Exclusion Criteria
- Presence or history of any clinically relevant abnormality, condition, or disease (such as liver disease or abnormal liver function tests, or cardiovascular or pulmonary diseases) that, in the opinion of the investigator, may affect absorption, distribution, metabolism, or elimination of the study intervention, that would prevent the participant from participating in the study, or which places the participant at unacceptable risk if she were to participate in the study.
- Current or recent (within 3 months of study intervention administration) clinically significant gastrointestinal disease that, in the opinion of the investigator, could impact upon the absorption of study intervention.
- Presence or history of mastitis, breast surgery or trauma, or other breast conditions, which are considered clinically significant by the investigator and/or, in the investigator's opinion, may significantly impact breastfeeding or collection of milk from one or both breasts.
- History of biliary disorders, including Gilbert's syndrome or Dubin-Johnson disease, except for isolated gallbladder issues, which are not by themselves exclusionary.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Data sourced from ClinicalTrials.gov (NCT06476834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.