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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Psoriasis; Inflammatory Bowel Diseases; Systemic Lupus Erythematosus; Arthritic Psoriasis

Treatments: Drug: BMS-986165 Tablet; Drug: BMS-986165 Capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT03254784

IM011-031

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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49 participants in 6 patient groups

Tablet-Capsule Crossover 1

Experimental group

Description:

Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations

Treatment:

Drug: BMS-986165 Capsule

Drug: BMS-986165 Tablet

Tablet-Capsule Crossover 2

Experimental group

Description:

Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations

Treatment:

Drug: BMS-986165 Capsule

Drug: BMS-986165 Tablet

Tablet-Capsule Crossover 3

Experimental group

Description:

Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations

Treatment:

Drug: BMS-986165 Capsule

Drug: BMS-986165 Tablet

Tablet-Capsule Crossover 4

Experimental group

Description:

Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations

Treatment:

Drug: BMS-986165 Capsule

Drug: BMS-986165 Tablet

Tablet-Capsule Crossover 5

Experimental group

Description:

Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations

Treatment:

Drug: BMS-986165 Capsule

Drug: BMS-986165 Tablet

Tablet-Capsule Crossover 6

Experimental group

Description:

Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations

Treatment:

Drug: BMS-986165 Capsule

Drug: BMS-986165 Tablet