Clinical trial NCT06476834: A Study Evaluating Deucravacitinib Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants
Official title: A Phase IV, Open-label, Single-group, Single-dose Study Evaluating Deucravacitinib Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Volunteers
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-06-26
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Maximum observed milk concentration (Cmax)
timeFrame: Up to 72 hours
measure: Time of maximum observed milk concentration (Tmax)
timeFrame: Up to 72 hours
measure: Area under the milk concentration-time curve from time zero to 24 hours (AUC(0-24))
timeFrame: Up to 72 hours
measure: Area under the milk concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
timeFrame: Up to 72 hours
measure: Average milk concentration (Cavg)
timeFrame: Up to 72 hours
measure: Amount recovered in milk within 24 hours of dosing (AR(24))
timeFrame: Up to 72 hours
measure: Total amount recovered in milk (AR)
timeFrame: Up to 72 hours
measure: Milk-plasma ratio (M/P)
timeFrame: Up to 72 hours
measure: Estimated daily infant dose of deucravacitinib
timeFrame: Up to 72 hours
measure: Relative infant dose of deucravacitinib
timeFrame: Up to 72 hours
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 72 hours
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
timeFrame: Up to 72 hours
measure: Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24))
timeFrame: Up to 72 hours
measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
timeFrame: Up to 72 hours
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to 72 hours
measure: Average plasma concentration (Cavg)
timeFrame: Up to 72 hours
measure: Number of participants with Treatment Emergent Adverse Events
timeFrame: Up to Day 30
measure: Number of participants with clinical laboratory test abnormalities
timeFrame: Up to Day 30
measure: Number of participants with vital sign abnormalities
timeFrame: Up to Day 30
measure: Number of participants with physical examination abnormalities
timeFrame: Up to Day 30
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to Day 30
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Local Institution - 0001
state: Nevada
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: