WithdrawnNCT04464577Updated Mar 25, 2022

A Study to Evaluate the Effect of Fluconazole, Bupropion, or Itraconazole on the Drug Levels and Safety of BMS-986235

A Phase 1 interventional study of Fluconazole and Bupropion in Healthy Participants, sponsored by Bristol-Myers Squibb. Withdrawn at 2 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-25.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment

Why this study was withdrawn

Business objectives have changed.

Phase: Phase 1
Study type: Interventional
Enrollment: 0
Allocation: Non-randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Conditions studied

Healthy Participants

In context

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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

Other protocol-defined inclusion/exclusion criteria apply

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 0 participants (actual)

Study arms

Experimental
Arm A: BMS-986235+Fluconazole
Drug: Fluconazole · Drug: BMS-986235
Experimental
Arm B: BMS-986235+ Bupropion
Drug: Bupropion · Drug: BMS-986235
Experimental
Arm C: BMS-986235+ Itraconazole
Drug: Itraconazole · Drug: BMS-986235

Interventions

DrugFluconazole
Specified Dose on Specified Days
DrugBupropion
Specified Dose on Specified Days
DrugItraconazole
Specified Dose on Specified Days
DrugBMS-986235
Specified Dose on Specified Days

What researchers measure

Primary outcomes

Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with fluconazole
Time frame: Day 12
Maximum plasma concentration (Cmax) of BMS-986235 with fluconazole
Time frame: Day 12
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with fluconazole
Time frame: Day 12
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with bupropion
Time frame: 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
Time frame: Day 13
Maximum plasma concentration (Cmax) of BMS-986235 with bupropion
Time frame: 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
Time frame: Day 9
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with itraconazole
Time frame: Day 9
Maximum plasma concentration (Cmax) of BMS-986235 with itraconazole
Time frame: Day 9
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235
Time frame: Day 1
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235
Time frame: Day 1
Maximum plasma concentration (Cmax) of BMS-986235
Time frame: Day 1

Secondary outcomes

Incidence of Nonserious Adverse Events (AEs)
Time frame: Up to 49 days
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 77 days
Incidence of AEs leading to discontinuation
Time frame: Up to 16 days
Number of clinically significant changes from baseline in vital signs: Body Temperature
Time frame: Up to 44 days
Number of clinically significant changes from baseline in physical examinations
Time frame: Up to 44 days
Number of clinically significant changes in clinical laboratory tests: Hematology
Time frame: Up to 44 days
Number of clinically significant changes in clinical laboratory tests: Clinical Chemistry
Time frame: Up to 44 days
Number of clinically significant changes in clinical laboratory tests: Coagulation
Time frame: Up to 44 days
Number of clinically significant changes in clinical laboratory tests: Urinalysis
Time frame: Up to 44 days
Number of clinically significant changes from baseline in vital signs: Respiratory Rate
Time frame: Up to 44 days
Number of clinically significant changes from baseline in vital signs: Heart Rate
Time frame: Up to 44 days
Number of clinically significant changes from baseline in vital signs:Blood Pressure
Time frame: Up to 44 days
Number of clinically significant changes in electrocardiogram (ECG)
Time frame: Up to 44 days
Number of clinically significant changes in vital signs: Oxygen saturation (the amount of oxygen in blood (SpO2))
Time frame: Up to 44 days

Study locations

2 sites

Local Institution
Lenexa, Kansas 66219, United States
Local Institution
Salt Lake City, Utah 84124, United States

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04464577
Lead sponsor: Bristol-Myers Squibb
Responsible party: Sponsor
First posted: Jul 9, 2020
Start date: Apr 1, 2021 (estimated)
Primary completion: Jun 7, 2021 (estimated)
Completion: Jun 8, 2021 (estimated)
Last update: Mar 25, 2022

Study contacts

Bristol-Myers Squibb

study director · Bristol-Myers Squibb

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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