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

Phase 1

Withdrawn

• Conditions: Healthy Participants
• Interventions: Drug: Fluconazole; Drug: Itraconazole; Drug: Bupropion; Drug: BMS-986235

• Registration Number: NCT04464577
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-07-06
• Study First Posted: 2020-07-09
• Study Start: 2021-04-01
• Primary Completion: 2021-06-07
• Study Completion: 2021-06-08
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-10
• Last Update Posted: 2022-03-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: BMS-986235+Fluconazole	BMS-986235	-
Arm B: BMS-986235+ Bupropion	BMS-986235	-
Arm C: BMS-986235+ Itraconazole	BMS-986235	-
Arm A: BMS-986235+Fluconazole	Fluconazole	-
Arm C: BMS-986235+ Itraconazole	Itraconazole	-
Arm B: BMS-986235+ Bupropion	Bupropion	-

Primary Outcome Measures

Name	Time	Method
Maximum plasma concentration (Cmax) of BMS-986235 with itraconazole	Day 9
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 bupropion	Day 13
Maximum plasma concentration (Cmax) of BMS-986235 with bupropion	Day 13
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 to time of last quantifiable concentration (AUC(0-T)) 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 fluconazole	Day 12
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
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

Name	Time	Method
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 in clinical laboratory tests: Clinical Chemistry	Up to 44 days
Number of clinically significant changes in clinical laboratory tests: Urinalysis	Up to 44 days
Incidence of Serious Adverse Events (SAEs)	Up to 77 days
Number of clinically significant changes in clinical laboratory tests: Hematology	Up to 44 days
Number of clinically significant changes in clinical laboratory tests: Coagulation	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 in electrocardiogram (ECG)	Up to 44 days
Number of clinically significant changes from baseline in physical examinations	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
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:Blood Pressure	Up to 44 days

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Salt Lake City, Utah, United States