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

Bristol-Myers Squibb8 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

DeucravacitinibDRUG

Specified dose on specified days

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Local Institution - 0001

Las Vegas, Nevada, United States

Outcomes

Primary Outcomes

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

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

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

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

Tmax is defined as the time taken to reach the 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

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

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.

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

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

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.

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

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

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

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

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

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

Time frame: From first dose day 1 up to 24 hours post dose

Data from ClinicalTrials.gov

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Secondary Outcomes

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

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

Time frame: 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

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.

Time frame: 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

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.

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

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

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.

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

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

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

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

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

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

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

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

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.

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

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

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

Time frame: 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)

Time frame: 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)

Time frame: 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)

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