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

A Phase 1, Open-label, Crossover Study to Evaluate the Pharmacokinetics of Deucravacitinib (BMS-986165) Administered as Various Solid Tablet Formulations in Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Deucravacitinib; Drug: Famotidine

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33126
      • Quotient Sciences Miami
  • Texas
    • Austin, Texas, United States, 78744
      • PPD Development, LP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A	Drug: Deucravacitinib; Specified dose on specified days; Other Names: BMS-986165
Experimental: Part B	Drug: Deucravacitinib; Specified dose on specified days; Other Names: BMS-986165
Experimental: Part C	Drug: Deucravacitinib; Specified dose on specified days; Other Names: BMS-986165; Drug: Famotidine; Specified dose on specified days; Other Names: Pepcid
Experimental: Part D	Drug: Deucravacitinib; Specified dose on specified days; Other Names: BMS-986165

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Incidence of clinically significant changes in vital signs: Body temperature		Up to 11 days
Incidence of clinically significant changes in vital signs: Respiratory rate		Up to 11 days
Incidence of clinically significant changes in vital signs: Blood pressure		Up to 11 days
Incidence of clinically significant changes in vital signs: Heart rate		Up to 11 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval	PR interval is the time from the onset of the P wave to the start of the QRS complex	Up to 11 days
Incidence of clinically significant changes in ECG parameters: QRS	QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization	Up to 11 days
Incidence of clinically significant changes in ECG parameters: QT interval	The QT interval is the time from the start of the Q wave to the end of the T wave	Up to 11 days
Incidence of clinically significant changes in ECG parameters: QTcF	QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave	Up to 11 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2021
• Primary Completion (Actual): January 3, 2022
• Study Completion (Actual): January 3, 2022

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: June 30, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: February 24, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Deucravacitinib; BMS-986165; Healthy Participants
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Dermatologic Agents; Protein Kinase Inhibitors; Anti-Ulcer Agents; Histamine Antagonists; Histamine Agents; Histamine H2 Antagonists; Famotidine; BMS-986165
• Other Study ID Numbers: IM011-120

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No