NCT04113668

Brief Summary

BMS-986165 Is broken down by the body through multiple pathways. This study Investigates the effect of blocking one pathway in the drug levels of BMS-986165 in health subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2019

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

October 1, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2019

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2019

Completed
Last Updated

August 5, 2020

Status Verified

August 1, 2020

Enrollment Period

2 months

First QC Date

October 1, 2019

Last Update Submit

August 3, 2020

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (3)

  • Maximum observed plasma concentration (Cmax) of BMS-986165 with and without UGT1A9 inhibitor

    Up to 14 days

  • Area under the plasma concentration-time AUC (0-T) of BMS-986165 with and without UGT1A9 inhibitor

    up to 14 days

  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time AUC(INF) for BMS-986165 with and without UGT1A9 inhibitor

    up to 14 days

Secondary Outcomes (9)

  • Incidence of Adverse Events (AEs)

    up to 48 days

  • Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities

    up to 48 days

  • Physical Examination of weight

    up to 48 days

  • Number of changes in blood pressure

    up to 20 days

  • Number of changes in body temperature

    up to 20 days

  • +4 more secondary outcomes

Study Arms (2)

Arm A: Single Dose (BMS-986165)

EXPERIMENTAL
Drug: BMS-986165

Arm B:Diflunisal and Single Dose (BMS-986165)

EXPERIMENTAL
Drug: BMS-986165Drug: diflunisal

Interventions

BMS-986165DRUG

Specified Dose on Specified Days

Arm A: Single Dose (BMS-986165)Arm B:Diflunisal and Single Dose (BMS-986165)
diflunisalDRUG

Specified Dose on Specified Days

Arm B:Diflunisal and Single Dose (BMS-986165)

Eligibility Criteria

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

You may qualify if:

  • Women and men must agree to follow instructions for methods of contraception.
  • Participants must be willing and able to complete all study-specific procedures and visits.
  • A healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
  • WOCBP must have a negative serum or urine pregnancy test within 24 hours prior to the start of study treatment.

You may not qualify if:

  • Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of active liver disease
  • History of biliary disorders, including Gilbert's syndrome or Dubin- Johnson disease, in addition to, current or recent gastrointestinal disease that could impact the absorption of study drug.
  • Participants using electronic cigarettes or nicotine-containing products who have stopped smoking less than 6 months prior to dosing on Day 1.
  • Consumption of chargrilled meat, quinine, or any nutrient known to modulate CYP enzyme activity within 14 days prior to first administration of study treatment.
  • History of any significant drug allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PRA Health Sciences - Lenexa

Lenexa, Kansas, 66219, United States

Location

Related Links

MeSH Terms

Interventions

deucravacitinibDiflunisal

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 1, 2019

First Posted

October 3, 2019

Study Start

October 1, 2019

Primary Completion

November 19, 2019

Study Completion

November 25, 2019

Last Updated

August 5, 2020

Record last verified: 2020-08

Locations

US(1)