Clinical trial NCT04464577: A Study to Evaluate the Effect of Fluconazole, Bupropion, or Itraconazole on the Drug Levels and Safety of BMS-986235
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-07-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with fluconazole
timeFrame: Day 12
measure: Maximum plasma concentration (Cmax) of BMS-986235 with fluconazole
timeFrame: Day 12
measure: Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with fluconazole
timeFrame: Day 12
measure: Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with bupropion
timeFrame: Day 13
measure: Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with bupropion
timeFrame: Day 13
measure: Maximum plasma concentration (Cmax) of BMS-986235 with bupropion
timeFrame: Day 13
measure: Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with itraconazole
timeFrame: Day 9
measure: Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with itraconazole
timeFrame: Day 9
measure: Maximum plasma concentration (Cmax) of BMS-986235 with itraconazole
timeFrame: Day 9
measure: Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235
timeFrame: Day 1
measure: Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235
timeFrame: Day 1
measure: Maximum plasma concentration (Cmax) of BMS-986235
timeFrame: Day 1
Secondary outcomes:
measure: Incidence of Nonserious Adverse Events (AEs)
timeFrame: Up to 49 days
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to 77 days
measure: Incidence of AEs leading to discontinuation
timeFrame: Up to 16 days
measure: Number of clinically significant changes from baseline in vital signs: Body Temperature
timeFrame: Up to 44 days
measure: Number of clinically significant changes from baseline in physical examinations
timeFrame: Up to 44 days
measure: Number of clinically significant changes in clinical laboratory tests: Hematology
timeFrame: Up to 44 days
measure: Number of clinically significant changes in clinical laboratory tests: Clinical Chemistry
timeFrame: Up to 44 days
measure: Number of clinically significant changes in clinical laboratory tests: Coagulation
timeFrame: Up to 44 days
measure: Number of clinically significant changes in clinical laboratory tests: Urinalysis
timeFrame: Up to 44 days
measure: Number of clinically significant changes from baseline in vital signs: Respiratory Rate
timeFrame: Up to 44 days
measure: Number of clinically significant changes from baseline in vital signs: Heart Rate
timeFrame: Up to 44 days
measure: Number of clinically significant changes from baseline in vital signs:Blood Pressure
timeFrame: Up to 44 days
measure: Number of clinically significant changes in electrocardiogram (ECG)
timeFrame: Up to 44 days
measure: Number of clinically significant changes in vital signs: Oxygen saturation (the amount of oxygen in blood (SpO2))
timeFrame: Up to 44 days
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: Local Institution
state: Kansas
city: Salt Lake City
country: United States
facility: Local Institution
state: Utah
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: