NCT04209699

Brief Summary

The primary purpose of this study is to evaluate the effects of food and pH on the relative bioavailability (BA) of the tablet formulation of BMS-986165 in healthy volunteers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 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

December 23, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 24, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

December 27, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2020

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2020

Completed
Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

1 month

First QC Date

December 23, 2019

Last Update Submit

April 20, 2020

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (6)

  • Maximum observed plasma concentration (Cmax) for BMS-986165 for tablet dosed with high-fat high-calorie meal versus fasted condition

    Day 1 to Day 13

  • Maximum observed plasma concentration (Cmax) for BMS-986165 for tablet administered fasted after pretreatment with famotidine vs administered alone

    Day 1 to Day 13

  • Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) in plasma for BMS-986165 for a tablet dosed with high-fat high-calorie meal versus fasted condition

    Day 1 to Day 13

  • Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) in plasma for BMS-986165 for tablet administered fasted after pretreatment with famotidine vs administered alone

    Day 1 to Day 13

  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) in plasma for BMS-986165 for tablet dosed with high-fat high-calorie meal versus fasted condition

    Day 1 to Day 13

  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) in plasma for BMS-986165 for tablet administered fasted after pretreatment with famotidine vs administered alone

    Day 1 to Day 13

Secondary Outcomes (4)

  • Incidence of Adverse Events (AEs)

    Up to 39 days

  • Number of clinically significant changes in vital sign measurements

    Up to 18 days

  • Number of clinically significant changes in clinical laboratory test results

    Up to 18 days

  • Number of clinically significant changes in electrocardiogram (ECG) parameters

    Up to 18 days

Study Arms (3)

Treatment A: BMS-986165 alone, fasted

EXPERIMENTAL
Drug: BMS-986165

Treatment B: BMS-986165 alone, fed

EXPERIMENTAL
Drug: BMS-986165

Treatment C: BMS-986165 with famotidine pretreatment, fasted

EXPERIMENTAL
Drug: BMS-986165Drug: Famotidine

Interventions

BMS-986165DRUG

Single dose

Treatment A: BMS-986165 alone, fastedTreatment B: BMS-986165 alone, fedTreatment C: BMS-986165 with famotidine pretreatment, fasted
FamotidineDRUG

Single dose

Treatment C: BMS-986165 with famotidine pretreatment, fasted

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index of 18.0 kg/m\^2 to 32.0 kg/m\^2, inclusive, and body weight ≥ 50 kg, at screening
  • Male and female paritcipants, aged 18 years, or age of majority, to age 55 years, inclusive
  • All female subjects must have a negative serum or urine pregnancy test

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 or active liver disease.
  • History of administration of live vaccines within 60 days before screening until clinic discharge
  • Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PRA Health Sciences - Salt Lake

Salt Lake City, Utah, 84124, United States

Location

Related Links

MeSH Terms

Interventions

deucravacitinibFamotidine

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

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

December 23, 2019

First Posted

December 24, 2019

Study Start

December 27, 2019

Primary Completion

February 4, 2020

Study Completion

February 11, 2020

Last Updated

April 21, 2020

Record last verified: 2020-04

Locations

US(1)