A Study to Evaluate BMS-986165 Tablet Formulation Relative to BMS-986165 Capsule Formulation and the Effect of a High-Fat/ High-Calorie Meal and Increased Gastric pH on the BMS-986165 Tablet Formulation

• Status: Completed
• Trial end date: 2017-11-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate BMS-986165 tablet formulation versus BMS-986165 capsule formulation. This study will also evaluate the effect of a high-fat/ high-calorie meal and increased gastric pH on the BMS-986165 tablet formulation.

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

Details

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

Criteria

Inclusion Criteria:

• Patients must be willing and able to complete all study-specific procedures and visits

• Healthy patients, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram, and clinical laboratory determinations

• Body mass index (BMI) of 18 to 32 kg/m2, inclusive, at screening

• Normal renal function at screening

Exclusion Criteria:

• Women of childbearing potential not using an effective contraceptive method or are breastfeeding

• Any significant acute or chronic medical illness

• History of chronic headaches, defined as occurring 15 days or more a month, over the previous 3 months

• History of headaches related to caffeine withdrawal, including energy drinks

• History of syncope, orthostatic instability, or recurrent dizziness

• Active TB requiring treatment or documented latent TB within the previous 3 years

Other protocol defined inclusion/exclusion criteria could apply.