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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Prototype BMS-986165; Drug: Reference Treatment- BMS-986165-01; Drug: Famotidine; Other: Alcohol

Study type: Interventional

Funder types: Industry

Identifiers

NCT04536961

IM011-136

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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56 participants in 9 patient groups

Part A: Reference Treatment

Experimental group

Treatment:

Drug: Reference Treatment- BMS-986165-01

Part A Prototype

Experimental group

Treatment:

Drug: Prototype BMS-986165

Part C Reference Treatment

Experimental group

Treatment:

Drug: Reference Treatment- BMS-986165-01

Part C: Prototype

Experimental group

Treatment:

Drug: Prototype BMS-986165

Part B: Treatment 1

Experimental group

Treatment:

Drug: Prototype BMS-986165

Part B: Treatment 2

Experimental group

Treatment:

Drug: Prototype BMS-986165

Part B: Treatment 3

Experimental group

Treatment:

Drug: Prototype BMS-986165

Part B: Treatment 4

Experimental group

Treatment:

Drug: Famotidine

Drug: Prototype BMS-986165

Part B: Treatment 5

Experimental group

Treatment:

Other: Alcohol

Drug: Prototype BMS-986165