A Study to Evaluate the Drug Levels of Deucravacitinib From Tablets After Oral Administration in Healthy Participants

NCT04949269 | Completed Phase 1 FDA Drug

• 1 other identifier: IM011-120
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to assess the drug levels of deucravacitinib after oral administration in healthy participants.

Conditions

Healthy Participants

Keywords

Healthy Participants; Deucravacitinib; BMS-986165

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Plasma Concentration (Cmax) of deucravacitinib

  Up to 7 days

• Area Under the Concentration-time Curve from time 0 to 24 hours postdose (AUC(0-24)) of deucravacitinib

  Up to 7 days

• Concentration at 24 hours of post-morning dose on Day 1 and Day 7 (C24) of deucravacitinib

  Up to 7 days

Secondary Outcomes (13)

• Incidence of non-serious Adverse Events (AEs)

  Up to 18 days

• Incidence of Serious Adverse Events (SAEs)

  Up to 30 days post discontinuation of dosing or participant's participation in the study

• Incidence of clinically significant changes in clinical laboratory values: Hematology tests

  Up to 11 days

• Incidence of clinically significant changes in clinical laboratory values: Chemistry tests

  Up to 11 days

• Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests

  Up to 11 days

Study Arms (4)

Part A

EXPERIMENTAL

Drug: Deucravacitinib

Part B

EXPERIMENTAL

Drug: Deucravacitinib

Part C

EXPERIMENTAL

Drug: Deucravacitinib; Drug: Famotidine

Part D

EXPERIMENTAL

Drug: Deucravacitinib

Interventions

Deucravacitinib DRUG

Specified dose on specified days

Also known as: BMS-986165

Part A; Part B; Part C; Part D

Famotidine DRUG

Specified dose on specified days

Also known as: Pepcid

Part C

Eligibility Criteria

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

You may qualify if:

• Healthy participants, as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory determinations.
• Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and total body weight ≥50 kg (110 lb).
• Willing and able to consume 4 units of alcohol (Part C only). Only participants with low to moderate alcohol consumption will be enrolled in Part C of this study (ie, consumption of between 1 and 21 units per week for males and between 1 and 14 units per week in females).

You may not qualify if:

• Current or recent (within 3 months or 90 days of study drug administration) clinically significant gastrointestinal disease that, in the opinion of the investigator or medical monitor, could impact upon the absorption of study drug.
• Any medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease.
• Clinically significant history or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months or 90 days prior to screening.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Quotient Sciences Miami

Miami, Florida, 33126, United States

Location

PPD Development, LP

Austin, Texas, 78744, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls
• Investigator Inquiry Form

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: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 2, 2021
• Study Start: July 20, 2021
• Primary Completion: January 3, 2022
• Study Completion: January 3, 2022
• Last Updated: March 11, 2022

Record last verified: 2022-02

Locations

US (2)