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

NCT06851871 | Completed Phase 1 FDA Drug

• 1 other identifier: IM011-1178
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Keywords

Bioequivalence; Food Effect; pH Effect; Healthy Volunteers; Deucravacitinib

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Incidence of adverse events (AEs)

  Up to day 44

• Incidence of serious adverse events (SAEs)

  Up to day 44

• Incidence of AEs leading to discontinuation

  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

Study Arms (4)

BMS-986165 Formulation 1

EXPERIMENTAL

Drug: Deucravacitinib

BMS-986165 Formulation 2

EXPERIMENTAL

Drug: Deucravacitinib

BMS-986165 Formulation 2 + Fed

EXPERIMENTAL

Drug: Deucravacitinib

BMS-986165 Formulation 2 + Famotidine

EXPERIMENTAL

Drug: Deucravacitinib; Drug: Famotidine

Interventions

Deucravacitinib DRUG

Specified dose on specified days

BMS-986165 Formulation 1; BMS-986165 Formulation 2; BMS-986165 Formulation 2 + Famotidine; BMS-986165 Formulation 2 + Fed

Famotidine DRUG

Specified dose on specified days

BMS-986165 Formulation 2 + Famotidine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must be healthy as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory determinations in the opinion of the investigator.
• Participants must be willing and able to complete all study-specific procedures and visits.
• Participants must have a body mass index of 18.0 kg/m2 through 32.0 kg/m2, inclusive, and total body weight ≥ 50 kg (110 lb).

You may not qualify if:

• Participants must not have any significant acute or chronic medical illness that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of/or acute liver disease in the opinion of the Investigator.
• Participants must not have evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory determinations beyond what is consistent with the population reference ranges in the opinion of the investigator.
• Participants must not have any history of severe reaction to a drug (eg, anaphylactic, anaphylactoid, Stevens-Johnson, angioedematous), or adverse or allergic/hypersensitivity reaction to multiple drugs.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Austin, Texas, 78744, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

deucravacitinib; Famotidine

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 28, 2025
• Study Start: January 23, 2025
• Primary Completion: April 4, 2025
• Study Completion: April 4, 2025
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

US (1)