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
Completed · Phase 1
Conditions studied: Systemic Lupus Erythematosus, Arthritic Psoriasis, Psoriasis, Inflammatory Bowel Diseases
In brief
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.
Key facts
- Study ID
- NCT03254784
- Run by
- Bristol-Myers Squibb
- People needed
- 49
- Starts
- 2017-09-13
- Expected to finish
- 2017-11-15
- Last updated by the study team
- 2020-02-25
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- PRA Health Sciences — Lenexa, Kansas, United States
Full record on ClinicalTrials.gov
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