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

A Phase 1, Open-label Study to Evaluate the Effect of Fluconazole, Bupropion, or Itraconazole on the Pharmacokinetics and Safety of BMS-986235

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.

Study Overview

• Status: Withdrawn
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Itraconazole; Drug: Fluconazole; Drug: BMS-986235; Drug: Bupropion

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm A: BMS-986235+Fluconazole	Drug: Fluconazole; Specified Dose on Specified Days; Drug: BMS-986235; Specified Dose on Specified Days
EXPERIMENTAL: Arm B: BMS-986235+ Bupropion	Drug: BMS-986235; Specified Dose on Specified Days; Drug: Bupropion; Specified Dose on Specified Days
EXPERIMENTAL: Arm C: BMS-986235+ Itraconazole	Drug: Itraconazole; Specified Dose on Specified Days; Drug: BMS-986235; Specified Dose on Specified Days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2021
• Primary Completion (ANTICIPATED): June 7, 2021
• Study Completion (ANTICIPATED): June 8, 2021

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (ACTUAL): July 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 10, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; Dopamine Uptake Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Bupropion; Itraconazole; Fluconazole
• Other Study ID Numbers: CV018-014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No