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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03950960
• Other study ID #: IM026-020
• Status: Completed
• Phase: Phase 1
• Start date: May 2, 2019
• Est. completion date: August 7, 2019

Study information

• Verified date: February 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 7, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BMS-986256
Specified dose on specified days
• Itraconazole
Specified dose on specified days

Locations

Country	Name	City	State
United States	PRA Health Sciences - Lenexa	Lenexa	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of BMS-986256		After single dose on Days 1 and 29
Primary	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
Primary	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	Percentage of Participants with Adverse Events (AEs)		From the time of study treatment administration through the final study visit (Up to 55 days)
Secondary	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)
Secondary	Percentage of Participants with Vital Signs, Electrocardiograms (ECGs), and Physical Examinations Abnormalities		From screening to follow-up (Up to 55 days)

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form