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

Phase 1

Completed

• Conditions: Inflammatory Bowel Diseases; Systemic Lupus Erythematosus; Arthritic Psoriasis; Psoriasis
• Interventions: Drug: BMS-986165 Capsule; Drug: BMS-986165 Tablet

• Registration Number: NCT03254784
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-17
• Study First Submitted QC: 2017-08-17
• Study First Posted: 2017-08-18
• Study Start: 2017-09-13
• Primary Completion: 2017-11-04
• Study Completion: 2017-11-15
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tablet-Capsule Crossover 3	BMS-986165 Tablet	Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Tablet-Capsule Crossover 6	BMS-986165 Tablet	Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Tablet-Capsule Crossover 5	BMS-986165 Capsule	Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Tablet-Capsule Crossover 2	BMS-986165 Tablet	Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Tablet-Capsule Crossover 3	BMS-986165 Capsule	Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Tablet-Capsule Crossover 1	BMS-986165 Tablet	Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Tablet-Capsule Crossover 4	BMS-986165 Capsule	Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Tablet-Capsule Crossover 4	BMS-986165 Tablet	Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Tablet-Capsule Crossover 5	BMS-986165 Tablet	Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Tablet-Capsule Crossover 2	BMS-986165 Capsule	Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Tablet-Capsule Crossover 1	BMS-986165 Capsule	Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Tablet-Capsule Crossover 6	BMS-986165 Capsule	Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations

Primary Outcome Measures

Name	Time	Method
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
Maximum observed plasma concentration (Cmax) derived from plasma concentration versus time	5 days

Secondary Outcome Measures

Name	Time	Method
Serious adverse events measured by incidence	Approximately 55 days
Adverse events measured by incidence	26 days

Trial Locations

Locations (1)

PRA Health Sciences; 🇺🇸 Lenexa, Kansas, United States