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

NCT03950960 | Completed Phase 1 FDA Drug

• 1 other identifier: IM026-020
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Keywords

Cytochrome P450 3A4 Inhibition

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Plasma Concentration (Cmax) of BMS-986256

  After single dose on Days 1 and 29

• 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

• 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 Outcomes (3)

• Percentage of Participants with Adverse Events (AEs)

  From the time of study treatment administration through the final study visit (Up to 55 days)

• 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)

• Percentage of Participants with Vital Signs, Electrocardiograms (ECGs), and Physical Examinations Abnormalities

  From screening to follow-up (Up to 55 days)

Study Arms (1)

BMS-986256 +Itraconazole

EXPERIMENTAL

Drug: BMS-986256; Drug: Itraconazole

Interventions

BMS-986256 DRUG

Specified dose on specified days

BMS-986256 +Itraconazole

Itraconazole DRUG

Specified dose on specified days

BMS-986256 +Itraconazole

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

PRA Health Sciences - Lenexa

Lenexa, Kansas, 66219, United States

Location

Related Links

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

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 15, 2019
• Study Start: May 2, 2019
• Primary Completion: July 31, 2019
• Study Completion: August 7, 2019
• Last Updated: February 25, 2020

Record last verified: 2020-02

Locations

US (1)