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

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: Deucravacitinib; Drug: Famotidine

• Registration Number: NCT06851871
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-22
• Study Start: 2025-01-23
• Study First Submitted QC: 2025-02-24
• Study First Posted: 2025-02-28
• Status Verified: 2025-04
• Primary Completion: 2025-04-04
• Study Completion: 2025-04-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BMS-986165 Formulation 1	Deucravacitinib	-
BMS-986165 Formulation 2	Deucravacitinib	-
BMS-986165 Formulation 2 + Fed	Deucravacitinib	-
BMS-986165 Formulation 2 + Famotidine	Deucravacitinib	-
BMS-986165 Formulation 2 + Famotidine	Famotidine	-

Primary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax)	Up to day 20
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))	Up to day 20
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))	Up to day 20

Secondary Outcome Measures

Name	Time	Method
Incidence of serious adverse events (SAEs)	Up to day 44
Incidence of AEs leading to discontinuation	Up to day 44
Incidence of adverse events (AEs)	Up to day 44
Number of participants with a clinically significant change from baseline in vital signs	Up to day 21
Number of participants with a change from baseline in 12-lead ECG results	Up to day 21
Apparent terminal plasma half-life (T-HALF)	Up to day 20
Number of participants with physical examination abnormalities	Up to day 21	A physical examination includes the assessment of the following: head, eyes, ears, nose, and throat (HEENT), cardiovascular (including peripheral vascular), lungs, abdomen, dermatological, and a general neurological examination
Time of maximum observed plasma concentration (Tmax)	Up to day 20
Apparent total body clearance (CLT/F)	Up to day 20

Trial Locations

Locations (1)

Local Institution - 0001; 🇺🇸 Austin, Texas, United States