A Study to Evaluate the Drug Levels of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy Participants

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

The purpose of this study is to evaluate the drug levels of BMS-986165 in when taken by mouth as various solid tablet prototypes, by healthy participants.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Famotidine; Drug: Reference Treatment- BMS-986165-01; Drug: Prototype BMS-986165; Other: Alcohol

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG11 6JS
    • Quotient Sciences Miami

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:

• No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (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). BMI = weight (kg)/(height [m])2 at screening.
• Willing and able to consume 4 units of alcohol (Part B only)
• A negative polymerase chain reaction (PCR) test for coronavirus disease 2019 (COVID-19) at screening and admission
• Males and females must agree to follow specific methods of contraception, if applicable

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: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: Reference Treatment	Drug: Reference Treatment- BMS-986165-01; Specified dose on specified days; Other Names: Deucravacitinib
Experimental: Part A Prototype	Drug: Prototype BMS-986165; Specified dose on specified days; Other Names: Deucravacitinib
Experimental: Part C Reference Treatment	Drug: Reference Treatment- BMS-986165-01; Specified dose on specified days; Other Names: Deucravacitinib
Experimental: Part C: Prototype	Drug: Prototype BMS-986165; Specified dose on specified days; Other Names: Deucravacitinib
Experimental: Part B: Treatment 1	Drug: Prototype BMS-986165; Specified dose on specified days; Other Names: Deucravacitinib
Experimental: Part B: Treatment 2	Drug: Prototype BMS-986165; Specified dose on specified days; Other Names: Deucravacitinib
Experimental: Part B: Treatment 3	Drug: Prototype BMS-986165; Specified dose on specified days; Other Names: Deucravacitinib
Experimental: Part B: Treatment 4	Drug: Famotidine; Specified dose on specified days; Drug: Prototype BMS-986165; Specified dose on specified days; Other Names: Deucravacitinib
Experimental: Part B: Treatment 5	Drug: Prototype BMS-986165; Specified dose on specified days; Other Names: Deucravacitinib; Other: Alcohol; Specified quantity on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum observed plasma concentration (Cmax) of BMS-986165		Day 1 and Day 7
Time of maximum observed plasma concentration (Tmax) of BMS-986165		Day 1 and Day 7
Area under the plasma concentration-time curve from time zero to t (AUC (0-t)) of BMS-986165	Part A, B, C	Day 1 and Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Nonserious Adverse Events (AEs)		Up to approximately 60 days (for Parts A & C), approximately 69 days (for Part B)
Incidence of Serious Adverse Events (AEs)		Up to approximately 83 days (for Parts A & C), approximately 92 days (for Part B)
Incidence of clinically significant changes in clinical laboratory results: Hematology tests		Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests		Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests		Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
Incidence of clinically significant changes in vital signs: Blood pressure		Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
Incidence of clinically significant changes in vital signs: Heart rate		Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
Incidence of clinically significant changes in vital signs: Respiratory rate		Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
Incidence of clinically significant changes in vital signs: Body temperature		Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
Incidence of clinically significant changes in electrocardiogram (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 approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS	QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization	Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
Incidence of clinically significant changes in electrocardiogram (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 approximately 53 days (for Parts A & C), approximately 62 days (for Part B)
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 approximately 53 days (for Parts A & C), approximately 62 days (for Part B)

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): September 10, 2020
• Primary Completion (Actual): December 25, 2020
• Study Completion (Actual): December 25, 2020

Study Registration Dates

• First Submitted: August 28, 2020
• First Submitted That Met QC Criteria: August 28, 2020
• First Posted (Actual): September 3, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Healthy volunteers
• 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: IM011-136

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes