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

Part of paid clinical trials in Las Vegas, Nevada.

Sponsor
Bristol-Myers Squibb
Study ID
NCT06476834
Phase
PHASE4
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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

Key Dates

Start date
Jun 24, 2024
Status verified
Nov 2025
Primary completion
Nov 2, 2024
Completion
Nov 2, 2024

Study Design

Enrollment
8 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Deucravacitinib Administration

Primary Outcome Measure

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Local Institution - 0001Las VegasNevada89113-2246-

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