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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03254784

Enrollment

Registered

2017-08-18

Start date

2017-09-13

Completion date

2017-11-15

Last updated

2020-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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 gastric pH on the BMS-986165 tablet formulation.

Interventions

DRUGBMS-986165 Capsule

Oral capsule

DRUGBMS-986165 Tablet

Oral tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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 Other protocol defined inclusion/

Design outcomes

Primary

Measure	Time frame
Maximum observed plasma concentration (Cmax) derived from plasma concentration versus time	5 days
AUC from time zero extrapolated to infinity [AUC(INF)] derived from plasma concentration versus time	5 days
Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration [AUC(0-T)] derived from plasma concentration versus time	5 days
Time of maximum observed plasma concentration (Tmax) derived from plasma concentration versus time	5 days

Secondary

Measure	Time frame
Adverse events measured by incidence	26 days
Serious adverse events measured by incidence	Approximately 55 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026