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

February 24, 2020 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • PRA Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Tablet-Capsule Crossover 1
Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Drug: BMS-986165 Capsule
Oral capsule
Drug: BMS-986165 Tablet
Oral tablet
EXPERIMENTAL: Tablet-Capsule Crossover 2
Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Drug: BMS-986165 Capsule
Oral capsule
Drug: BMS-986165 Tablet
Oral tablet
EXPERIMENTAL: Tablet-Capsule Crossover 3
Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Drug: BMS-986165 Capsule
Oral capsule
Drug: BMS-986165 Tablet
Oral tablet
EXPERIMENTAL: Tablet-Capsule Crossover 4
Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Drug: BMS-986165 Capsule
Oral capsule
Drug: BMS-986165 Tablet
Oral tablet
EXPERIMENTAL: Tablet-Capsule Crossover 5
Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Drug: BMS-986165 Capsule
Oral capsule
Drug: BMS-986165 Tablet
Oral tablet
EXPERIMENTAL: Tablet-Capsule Crossover 6
Variations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Drug: BMS-986165 Capsule
Oral capsule
Drug: BMS-986165 Tablet
Oral tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum observed plasma concentration (Cmax) derived from plasma concentration versus time
Time Frame: 5 days
5 days
AUC from time zero extrapolated to infinity [AUC(INF)] derived from plasma concentration versus time
Time Frame: 5 days
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
Time Frame: 5 days
5 days
Time of maximum observed plasma concentration (Tmax) derived from plasma concentration versus time
Time Frame: 5 days
5 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events measured by incidence
Time Frame: 26 days
26 days
Serious adverse events measured by incidence
Time Frame: Approximately 55 days
Approximately 55 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 13, 2017

Primary Completion (ACTUAL)

November 4, 2017

Study Completion (ACTUAL)

November 15, 2017

Study Registration Dates

First Submitted

August 17, 2017

First Submitted That Met QC Criteria

August 17, 2017

First Posted (ACTUAL)

August 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 24, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM011-031

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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