NCT03254784

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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 gastric pH on the BMS-986165 tablet formulation.

Conditions

• Systemic Lupus Erythematosus
• Arthritic Psoriasis
• Psoriasis
• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
DRUG	BMS-986165 Capsule	Oral capsule
DRUG	BMS-986165 Tablet	Oral tablet

Timeline

• Start date: 2017-09-13
• Primary completion: 2017-11-04
• Completion: 2017-11-15
• First posted: 2017-08-18
• Last updated: 2020-02-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study