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

• Status: Completed
• Trial end date: 2020-12-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: BMS-986165; Famotidine

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