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

Sponsors

Lead Sponsor: Bristol-Myers Squibb

Source 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.

Overall Status Not yet recruiting
Start Date April 1, 2021
Completion Date June 8, 2021
Primary Completion Date June 8, 2021
Phase Phase 1
Study Type Interventional
Primary 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
Measure Time Frame
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
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
Enrollment 42
Condition
Intervention

Intervention Type: Drug

Intervention Name: Fluconazole

Description: Specified Dose on Specified Days

Arm Group Label: Arm A: BMS-986235+Fluconazole

Intervention Type: Drug

Intervention Name: Bupropion

Description: Specified Dose on Specified Days

Arm Group Label: Arm B: BMS-986235+ Bupropion

Intervention Type: Drug

Intervention Name: Itraconazole

Description: Specified Dose on Specified Days

Arm Group Label: Arm C: BMS-986235+ Itraconazole

Intervention Type: Drug

Intervention Name: BMS-986235

Description: Specified Dose on Specified Days

Eligibility

Criteria:

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com. 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

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Bristol-Myers Squibb Study Director Bristol-Myers Squibb
Overall Contact

Last Name: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,

Phone: please email:

Email: [email protected]

Location
Facility: Contact:
Local Institution | Lenexa, Kansas, 66219, United States Site 0001
Local Institution | Salt Lake City, Utah, 84124, United States Site 0002
PRA Health Sciences - Salt Lake | Salt Lake City, Utah, 84124, United States
Location Countries

United States

Verification Date

July 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 3
Arm Group

Label: Arm A: BMS-986235+Fluconazole

Type: Experimental

Label: Arm B: BMS-986235+ Bupropion

Type: Experimental

Label: Arm C: BMS-986235+ Itraconazole

Type: Experimental

Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov