NCT06851871

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

A Phase 1, Open-label, Single-dose Study in Healthy Adult Participants to Assess the Bioequivalence Between Immediate Release Tablets and Minitablets, and to Assess the Food and pH Effect on the Pharmacokinetics of Deucravacitinib (BMS-986165) Administered as Minitablets

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Deucravacitinib	Specified dose on specified days
DRUG	Famotidine	Specified dose on specified days

Timeline

• Start date: 2025-01-23
• Primary completion: 2025-04-04
• Completion: 2025-04-04
• First posted: 2025-02-28
• Last updated: 2025-04-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study