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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04464577
• Other study ID #: CV018-014
• Status: Withdrawn
• Phase: Phase 1
• Start date: April 1, 2021
• Est. completion date: June 8, 2021

Study information

• Verified date: March 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 8, 2021
• Est. primary completion date: June 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Fluconazole
Specified Dose on Specified Days
• Bupropion
Specified Dose on Specified Days
• Itraconazole
Specified Dose on Specified Days
• BMS-986235
Specified Dose on Specified Days

Locations

Country	Name	City	State
United States	Local Institution	Lenexa	Kansas
United States	Local Institution	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Maximum plasma concentration (Cmax) of BMS-986235 with fluconazole		Day 12
Primary	Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with fluconazole		Day 12
Primary	Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with bupropion		Day 13
Primary	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
Primary	Maximum plasma concentration (Cmax) of BMS-986235 with bupropion		Day 13
Primary	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
Primary	Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with itraconazole		Day 9
Primary	Maximum plasma concentration (Cmax) of BMS-986235 with itraconazole		Day 9
Primary	Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235		Day 1
Primary	Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235		Day 1
Primary	Maximum plasma concentration (Cmax) of BMS-986235		Day 1
Secondary	Incidence of Nonserious Adverse Events (AEs)		Up to 49 days
Secondary	Incidence of Serious Adverse Events (SAEs)		Up to 77 days
Secondary	Incidence of AEs leading to discontinuation		Up to 16 days
Secondary	Number of clinically significant changes from baseline in vital signs: Body Temperature		Up to 44 days
Secondary	Number of clinically significant changes from baseline in physical examinations		Up to 44 days
Secondary	Number of clinically significant changes in clinical laboratory tests: Hematology		Up to 44 days
Secondary	Number of clinically significant changes in clinical laboratory tests: Clinical Chemistry		Up to 44 days
Secondary	Number of clinically significant changes in clinical laboratory tests: Coagulation		Up to 44 days
Secondary	Number of clinically significant changes in clinical laboratory tests: Urinalysis		Up to 44 days
Secondary	Number of clinically significant changes from baseline in vital signs: Respiratory Rate		Up to 44 days
Secondary	Number of clinically significant changes from baseline in vital signs: Heart Rate		Up to 44 days
Secondary	Number of clinically significant changes from baseline in vital signs:Blood Pressure		Up to 44 days
Secondary	Number of clinically significant changes in electrocardiogram (ECG)		Up to 44 days
Secondary	Number of clinically significant changes in vital signs: Oxygen saturation (the amount of oxygen in blood (SpO2))		Up to 44 days

External Links

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