Overview
A Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of BMS-986256 in Healthy Participants
Status:
Completed
Completed
Trial end date:
2019-08-07
2019-08-07
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to evaluate the effect of cytochrome P450 3A4 inhibition by Itraconazole on the pharmacokinetics of BMS-986256.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Bristol-Myers SquibbTreatments:
Hydroxyitraconazole
Itraconazole
Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, pleasevisit www.BMSStudyConnect.com
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