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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT03254784•Bristol-Myers Squibb

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (1)

PRA Health Sciences

Lenexa, Kansas, United States

Key Dates

Start Date

September 13, 2017

Primary Completion Date

November 4, 2017

Completion Date

November 15, 2017

Last Updated

February 25, 2020

Enrollment

ACTUAL participants

Conditions

Systemic Lupus ErythematosusArthritic PsoriasisPsoriasisInflammatory Bowel Diseases

Interventions

BMS-986165 Capsule

DRUG

BMS-986165 Tablet

DRUG

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Systemic Lupus Erythematosus (SLE)Rheumatoid Arthritis (RA)

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RECRUITINGPHASE1

A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 25, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)

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