Clinical trial NCT03950960: A Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of BMS-986256 in Healthy Participants
Official title: An Open-label, Single-Sequence, 2-Treatment Period Study to Investigate the Effects of Cytochrome P450 3A4 Inhibition by Itraconazole on the Pharmacokinetics of BMS-986256 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Cytochrome P450 3A4 Inhibition
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-05-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of BMS-986256
timeFrame: After single dose on Days 1 and 29
measure: Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T]) of BMS986256
timeFrame: After single dose on Days 1 and 29
measure: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) of BMS-986256
timeFrame: After single dose on Days 1 and 29
Secondary outcomes:
measure: Percentage of Participants with Adverse Events (AEs)
timeFrame: From the time of study treatment administration through the final study visit (Up to 55 days)
measure: Percentage of Participants with Serious Adverse Events (SAEs)
timeFrame: From the time ICF is signed through 30 days post dose, or the final study visit (Up to 60 days)
measure: Percentage of Participants with Vital Signs, Electrocardiograms (ECGs), and Physical Examinations Abnormalities
timeFrame: From screening to follow-up (Up to 55 days)
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: PRA Health Sciences - Lenexa
state: Kansas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: