Status:
COMPLETED
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
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Systemic Lupus Erythematosus
Arthritic Psoriasis
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief 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 ga...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2017
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03254784
Start Date
September 13 2017
End Date
November 15 2017
Last Update
February 25 2020
Active Locations (1)
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1
PRA Health Sciences
Lenexa, Kansas, United States, 66219