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

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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.


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.
We found this trial at
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Salt Lake City, Utah 84106
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Salt Lake City, UT
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