A Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of BMS-986256 in Healthy Participants
- Registration Number
- NCT03950960
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate the effect of cytochrome P450 3A4 inhibition by Itraconazole on the pharmacokinetics of BMS-986256.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
- Healthy participant, defined as having no clinically significant active or ongoing medical condition, physical examination abnormality, abnormal ECG finding, and abnormal clinical laboratory determinations that in the opinion of the Investigator would compromise the conduct, results, or interpretation of the study findings
- A negative QuantiFERON®-TB Gold test result at screening or documentation of a negative result within 3 months of the screening visit
- Weight greater than or equal to (>=) 50 kilogram (kg) and body mass index between 18.0 and 32.0 kilogram per meter square (kg/m^2) inclusive at screening
Exclusion Criteria
- Prior exposure to BMS-986256
- Previous investigational drug or placebo exposure within 6 weeks before nonbiologic study drug administration or 12 weeks before biologic study drug administration
- History or presence of malignancy including hematological malignancies. However, participants with a history of basal cell or squamous cell carcinoma that has been completely and successfully treated with no evidence of recurrence may not be excluded, at the discretion of the investigator
Other protocol defined inclusion/exclusion criteria could apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description BMS-986256 +Itraconazole BMS-986256 - BMS-986256 +Itraconazole Itraconazole -
- Primary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) of BMS-986256 After single dose on Days 1 and 29 Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T]) of BMS986256 After single dose on Days 1 and 29 Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) of BMS-986256 After single dose on Days 1 and 29
- Secondary Outcome Measures
Name Time Method Percentage of Participants with Adverse Events (AEs) From the time of study treatment administration through the final study visit (Up to 55 days) Percentage of Participants with Serious Adverse Events (SAEs) From the time ICF is signed through 30 days post dose, or the final study visit (Up to 60 days) Percentage of Participants with Vital Signs, Electrocardiograms (ECGs), and Physical Examinations Abnormalities From screening to follow-up (Up to 55 days)
Trial Locations
- Locations (1)
PRA Health Sciences - Lenexa
🇺🇸Lenexa, Kansas, United States