A Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of BMS-986256 in Healthy Participants

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Itraconazole; Drug: BMS-986256

Study type: Interventional

Funder types: Industry

Identifiers

NCT03950960

IM026-020

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of cytochrome P450 3A4 inhibition by Itraconazole on the pharmacokinetics of BMS-986256.

Enrollment: 15 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit 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

Trial design

15 participants in 1 patient group

BMS-986256 +Itraconazole

Experimental group

Treatment:

Drug: Itraconazole

Drug: BMS-986256