Skip to main content
OpenTrials
Completed

NCT Number: NCT06476834

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Local Institution - 0001

Las Vegas, Nevada, 89113-2246, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Deucravacitinib

Drug

Specified dose on specified days

Other names: BMS-986165, SOTYKTU®

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: First dose day 1 to day 4 up to 72 hours

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

  9. Average Estimated Daily Infant Dose

    Time frame: 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.

  10. Average Relative Infant Dose

    Time frame: 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.

Secondary outcomes

  1. Maximum Observed Concentration (Cmax) of BMS-986165 and BMT-153261 in Plasma

    Time frame: 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 plasma.

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

    Time frame: 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 plasma.

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

    Time frame: First dose day 1 up to 24 hours post dose

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

  4. 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

    Time frame: First dose day 1 to day 4 up to 72 hours

    AUC(0-T) defined as the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration of BMS-986165 and BMT-153261 in plasma.

  5. Time of Maximum Observed Concentration (Tmax) of BMS-986165 and BMT-153261 in Plasma

    Time frame: First dose day 1 to day 4 up to 72 hours

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

  6. Average Concentration (Cavg) of BMS-986165 and BMT-153261 in Plasma

    Time frame: First dose day 1 to day 4 up to 72 hours

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

  7. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Time frame: From the dose of study medication through 30 days (assessed for up to 30 days)

    Treatment-emergent Adverse event (TEAE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.

  8. Number of Participants With Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)

    Time frame: From the dose of study medication through 30 days (assessed for up to 30 days)

    Blood samples were collected to assess the abnormalities in laboratory parameters.

  9. Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)

    Time frame: From the dose of study medication through 30 days (assessed for up to 30 days)

    Treatment-emergent Adverse event (TEAE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.

  10. Number of Participants With Abnormal Physical Examinations Reported as Treatment-Emergent Adverse Events (TEAEs)

    Time frame: From the dose of study medication through 30 days (assessed for up to 30 days)

    Treatment-emergent Adverse event (TEAE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.

  11. Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as Treatment-Emergent Adverse Events (TEAEs)

    Time frame: From the dose of study medication through 30 days (assessed for up to 30 days)

    Treatment-emergent Adverse event (TEAE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 26, 2024
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.