A Study to Evaluate the Bioequivalence Between Immediate Release Tablets and Minitablets of Deucravacitinib (BMS-986165), and the Effect of Food and pH on the Drug Levels of the Minitablets in Healthy Adults

Part of paid clinical trials in Austin, Texas.

Sponsor
Bristol-Myers Squibb
Study ID
NCT06851871
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Deucravacitinib — DRUG
    Specified dose on specified days
  • Famotidine — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to evaluate the bioequivalence between immediate release tablets and minitablets of Deucravacitinib (BMS-986165), and the effect of food and pH on the drug levels of the minitablets in healthy adults.

Key Dates

Start date
Jan 23, 2025
Status verified
Apr 2025
Primary completion
Apr 4, 2025
Completion
Apr 4, 2025

Study Design

Enrollment
26 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: BMS-986165 Formulation 1
  • Experimental: BMS-986165 Formulation 2
  • Experimental: BMS-986165 Formulation 2 + Fed
  • Experimental: BMS-986165 Formulation 2 + Famotidine

Primary Outcome Measure

Maximum observed plasma concentration (Cmax) [ Time Frame: Up to day 20 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Local Institution - 0001AustinTexas78744-

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Local Institution - 0001· Austin, TX

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