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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

Primary Purpose

Systemic Lupus Erythematosus, Arthritic Psoriasis, Psoriasis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-986165 Capsule
BMS-986165 Tablet
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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/exclusion criteria could apply.

Sites / Locations

  • PRA Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Tablet-Capsule Crossover 1

Tablet-Capsule Crossover 2

Tablet-Capsule Crossover 3

Tablet-Capsule Crossover 4

Tablet-Capsule Crossover 5

Tablet-Capsule Crossover 6

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Maximum observed plasma concentration (Cmax) derived from plasma concentration versus time
AUC from time zero extrapolated to infinity [AUC(INF)] derived from plasma concentration versus time
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
Time of maximum observed plasma concentration (Tmax) derived from plasma concentration versus time

Secondary Outcome Measures

Adverse events measured by incidence
Serious adverse events measured by incidence

Full Information

First Posted
August 17, 2017
Last Updated
February 24, 2020
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03254784
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 13, 2017 (Actual)
Primary Completion Date
November 4, 2017 (Actual)
Study Completion Date
November 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus, Arthritic Psoriasis, Psoriasis, Inflammatory Bowel Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tablet-Capsule Crossover 1
Arm Type
Experimental
Arm Description
Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Arm Title
Tablet-Capsule Crossover 2
Arm Type
Experimental
Arm Description
Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Arm Title
Tablet-Capsule Crossover 3
Arm Type
Experimental
Arm Description
Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Arm Title
Tablet-Capsule Crossover 4
Arm Type
Experimental
Arm Description
Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Arm Title
Tablet-Capsule Crossover 5
Arm Type
Experimental
Arm Description
Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Arm Title
Tablet-Capsule Crossover 6
Arm Type
Experimental
Arm Description
Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Intervention Type
Drug
Intervention Name(s)
BMS-986165 Capsule
Intervention Description
Oral capsule
Intervention Type
Drug
Intervention Name(s)
BMS-986165 Tablet
Intervention Description
Oral tablet
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax) derived from plasma concentration versus time
Time Frame
5 days
Title
AUC from time zero extrapolated to infinity [AUC(INF)] derived from plasma concentration versus time
Time Frame
5 days
Title
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
Time Frame
5 days
Title
Time of maximum observed plasma concentration (Tmax) derived from plasma concentration versus time
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Adverse events measured by incidence
Time Frame
26 days
Title
Serious adverse events measured by incidence
Time Frame
Approximately 55 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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/exclusion criteria could apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
PRA Health Sciences
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States

12. IPD Sharing Statement

Links:
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

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

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