NCT04464577

Brief Summary

This study will evaluate the effect of inhibitors, at steady state, on the drug levels, safety, and tolerability of BMS-986235 when taken by healthy participants. The inhibitors to be utilized in this study are fluconazole, bupropion, and itraconazole.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2021

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
withdrawn

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

March 23, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2021

Completed
Last Updated

March 25, 2022

Status Verified

March 1, 2022

Enrollment Period

2 months

First QC Date

March 23, 2020

Last Update Submit

March 10, 2022

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (12)

  • Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with fluconazole

    Day 12

  • Maximum plasma concentration (Cmax) of BMS-986235 with fluconazole

    Day 12

  • Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with fluconazole

    Day 12

  • Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with bupropion

    Day 13

  • Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with bupropion

    Day 13

  • Maximum plasma concentration (Cmax) of BMS-986235 with bupropion

    Day 13

  • Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with itraconazole

    Day 9

  • Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with itraconazole

    Day 9

  • Maximum plasma concentration (Cmax) of BMS-986235 with itraconazole

    Day 9

  • Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235

    Day 1

  • Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235

    Day 1

  • Maximum plasma concentration (Cmax) of BMS-986235

    Day 1

Secondary Outcomes (14)

  • Incidence of Nonserious Adverse Events (AEs)

    Up to 49 days

  • Incidence of Serious Adverse Events (SAEs)

    Up to 77 days

  • Incidence of AEs leading to discontinuation

    Up to 16 days

  • Number of clinically significant changes from baseline in vital signs: Body Temperature

    Up to 44 days

  • Number of clinically significant changes from baseline in physical examinations

    Up to 44 days

  • +9 more secondary outcomes

Study Arms (3)

Arm A: BMS-986235+Fluconazole

EXPERIMENTAL
Drug: FluconazoleDrug: BMS-986235

Arm B: BMS-986235+ Bupropion

EXPERIMENTAL
Drug: BupropionDrug: BMS-986235

Arm C: BMS-986235+ Itraconazole

EXPERIMENTAL
Drug: ItraconazoleDrug: BMS-986235

Interventions

FluconazoleDRUG

Specified Dose on Specified Days

Arm A: BMS-986235+Fluconazole
BupropionDRUG

Specified Dose on Specified Days

Arm B: BMS-986235+ Bupropion
ItraconazoleDRUG

Specified Dose on Specified Days

Arm C: BMS-986235+ Itraconazole
BMS-986235DRUG

Specified Dose on Specified Days

Arm A: BMS-986235+FluconazoleArm B: BMS-986235+ BupropionArm C: BMS-986235+ Itraconazole

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening.
  • Males and females must agree to follow specific methods of contraception, if applicable.
  • Healthy participants, as determined by no clinically significant deviation from normal in physical examination, ECGs, and clinical laboratory determinations, and no significant findings in medical history.

You may not qualify if:

  • Women of childbearing potential (WOCBP), women who are pregnant or breastfeeding
  • Inability to tolerate oral medication
  • Known previous exposure to BMS-986235.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Local Institution

Lenexa, Kansas, 66219, United States

Location

Local Institution

Salt Lake City, Utah, 84124, United States

Location

Related Links

MeSH Terms

Interventions

FluconazoleBupropionItraconazole

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPropiophenonesKetonesOrganic ChemicalsPiperazines

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR
0

Study Design

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

Study Record Dates

First Submitted

March 23, 2020

First Posted

July 9, 2020

Study Start

April 1, 2021

Primary Completion

June 7, 2021

Study Completion

June 8, 2021

Last Updated

March 25, 2022

Record last verified: 2022-03

Locations

US(2)