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

NCT ID: NCT03254784

Last Updated: 2020-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-13

Study Completion Date

2017-11-15

Brief Summary

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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.

Detailed Description

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Conditions

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Systemic Lupus Erythematosus Arthritic Psoriasis Psoriasis Inflammatory Bowel Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tablet-Capsule Crossover 1

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

Group Type EXPERIMENTAL

BMS-986165 Capsule

Intervention Type DRUG

Oral capsule

BMS-986165 Tablet

Intervention Type DRUG

Oral tablet

Tablet-Capsule Crossover 2

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

Group Type EXPERIMENTAL

BMS-986165 Capsule

Intervention Type DRUG

Oral capsule

BMS-986165 Tablet

Intervention Type DRUG

Oral tablet

Tablet-Capsule Crossover 3

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

Group Type EXPERIMENTAL

BMS-986165 Capsule

Intervention Type DRUG

Oral capsule

BMS-986165 Tablet

Intervention Type DRUG

Oral tablet

Tablet-Capsule Crossover 4

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

Group Type EXPERIMENTAL

BMS-986165 Capsule

Intervention Type DRUG

Oral capsule

BMS-986165 Tablet

Intervention Type DRUG

Oral tablet

Tablet-Capsule Crossover 5

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

Group Type EXPERIMENTAL

BMS-986165 Capsule

Intervention Type DRUG

Oral capsule

BMS-986165 Tablet

Intervention Type DRUG

Oral tablet

Tablet-Capsule Crossover 6

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

Group Type EXPERIMENTAL

BMS-986165 Capsule

Intervention Type DRUG

Oral capsule

BMS-986165 Tablet

Intervention Type DRUG

Oral tablet

Interventions

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BMS-986165 Capsule

Oral capsule

Intervention Type DRUG

BMS-986165 Tablet

Oral tablet

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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PRA Health Sciences

Lenexa, Kansas, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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IM011-031

Identifier Type: -

Identifier Source: org_study_id

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