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 |
---|---|
Conditions: | Irritable Bowel Syndrome (IBS), Lupus, Psoriasis, Gastrointestinal |
Therapuetic Areas: | Dermatology / Plastic Surgery, Gastroenterology, Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 50 |
Updated: | 2/1/2019 |
Start Date: | September 13, 2017 |
End Date: | November 15, 2017 |
A Phase 1, Randomized, Open-Label, Single-Dose, Crossover Study To Evaluate the Bioavailability of 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 Bioavailability of BMS-986165 Tablet Formulation in Healthy Subjects
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.
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.
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.
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