NCT03254784

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2017

Completed
26 days until next milestone

Study Start

First participant enrolled

September 13, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2017

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2017

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

2 months

First QC Date

August 17, 2017

Last Update Submit

February 24, 2020

Conditions

Systemic Lupus ErythematosusArthritic PsoriasisPsoriasisInflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • Adverse events measured by incidence

    26 days

  • Serious adverse events measured by incidence

    Approximately 55 days

Study Arms (6)

Tablet-Capsule Crossover 1

EXPERIMENTAL

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

Drug: BMS-986165 CapsuleDrug: BMS-986165 Tablet

Tablet-Capsule Crossover 2

EXPERIMENTAL

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

Drug: BMS-986165 CapsuleDrug: BMS-986165 Tablet

Tablet-Capsule Crossover 3

EXPERIMENTAL

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

Drug: BMS-986165 CapsuleDrug: BMS-986165 Tablet

Tablet-Capsule Crossover 4

EXPERIMENTAL

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

Drug: BMS-986165 CapsuleDrug: BMS-986165 Tablet

Tablet-Capsule Crossover 5

EXPERIMENTAL

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

Drug: BMS-986165 CapsuleDrug: BMS-986165 Tablet

Tablet-Capsule Crossover 6

EXPERIMENTAL

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

Drug: BMS-986165 CapsuleDrug: BMS-986165 Tablet

Interventions

BMS-986165 CapsuleDRUG

Oral capsule

Tablet-Capsule Crossover 1Tablet-Capsule Crossover 2Tablet-Capsule Crossover 3Tablet-Capsule Crossover 4Tablet-Capsule Crossover 5Tablet-Capsule Crossover 6
BMS-986165 TabletDRUG

Oral tablet

Tablet-Capsule Crossover 1Tablet-Capsule Crossover 2Tablet-Capsule Crossover 3Tablet-Capsule Crossover 4Tablet-Capsule Crossover 5Tablet-Capsule Crossover 6

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PRA Health Sciences

Lenexa, Kansas, 66219, United States

Location

Related Links

MeSH Terms

Conditions

Lupus Erythematosus, SystemicArthritis, PsoriaticPsoriasisInflammatory Bowel Diseases

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesSkin Diseases, PapulosquamousSkin DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2017

First Posted

August 18, 2017

Study Start

September 13, 2017

Primary Completion

November 4, 2017

Study Completion

November 15, 2017

Last Updated

February 25, 2020

Record last verified: 2020-02

Locations

US(1)