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

NCT04536961 | Completed Phase 1 FDA Drug

• 1 other identifier: IM011-136
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (13)

• 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)

Study Arms (9)

Part A: Reference Treatment

EXPERIMENTAL

Drug: Reference Treatment- BMS-986165-01

Part A Prototype

EXPERIMENTAL

Drug: Prototype BMS-986165

Part C Reference Treatment

EXPERIMENTAL

Drug: Reference Treatment- BMS-986165-01

Part C: Prototype

EXPERIMENTAL

Drug: Prototype BMS-986165

Part B: Treatment 1

EXPERIMENTAL

Drug: Prototype BMS-986165

Part B: Treatment 2

EXPERIMENTAL

Drug: Prototype BMS-986165

Part B: Treatment 3

EXPERIMENTAL

Drug: Prototype BMS-986165

Part B: Treatment 4

EXPERIMENTAL

Drug: Prototype BMS-986165; Drug: Famotidine

Part B: Treatment 5

EXPERIMENTAL

Drug: Prototype BMS-986165; Other: Alcohol

Interventions

Reference Treatment- BMS-986165-01 DRUG

Specified dose on specified days

Also known as: Deucravacitinib

Part A: Reference Treatment; Part C Reference Treatment

Prototype BMS-986165 DRUG

Specified dose on specified days

Also known as: Deucravacitinib

Part A Prototype; Part B: Treatment 1; Part B: Treatment 2; Part B: Treatment 3; Part B: Treatment 4; Part B: Treatment 5; Part C: Prototype

Famotidine DRUG

Specified dose on specified days

Part B: Treatment 4

Alcohol OTHER

Specified quantity on specified days

Part B: Treatment 5

Eligibility Criteria

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

You may qualify if:

• 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

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 (1)

Quotient Sciences Miami

Nottingham, NG11 6JS, United Kingdom

Location

Related Links

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

MeSH Terms

Interventions

deucravacitinib; Famotidine; Ethanol

Intervention Hierarchy (Ancestors)

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

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: August 28, 2020
• First Posted: September 3, 2020
• Study Start: September 10, 2020
• Primary Completion: December 25, 2020
• Study Completion: December 25, 2020
• Last Updated: October 6, 2021

Record last verified: 2021-10

Locations

GB (1)