A Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of BMS-986256 in Healthy Participants
Completed · Phase 1
Conditions studied: Healthy Participants
In brief
The purpose of this study is to evaluate the effect of cytochrome P450 3A4 inhibition by Itraconazole on the pharmacokinetics of BMS-986256.
Key facts
- Study ID
- NCT03950960
- Run by
- Bristol-Myers Squibb
- People needed
- 15
- Starts
- 2019-05-02
- Expected to finish
- 2019-08-07
- Last updated by the study team
- 2020-02-25
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- PRA Health Sciences - Lenexa — Lenexa, Kansas, United States
Full record on ClinicalTrials.gov
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