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A Study in Healthy Men to Test Whether Itraconazole Influences the Amount of BI 1584862 in the Blood

NCT06041438 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-06-03

Study results available
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Summary

The main objective of this trial is to investigate the effect on the exposure of BI 1584862 in plasma when given as single dose together with multiple doses of itraconazole (Test, T) as compared to BI 1584862 when given alone as oral single dose (Reference, R).

Conditions

  • Healthy

Interventions

DRUG

BI 1584862

One dose with 240 mL of water after an overnight fast of at least 10 h

DRUG

Itraconazole

200 mg daily after an overnight fast of at least 9 h for several consecutive days

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-29
Primary Completion
2023-11-10
Completion
2023-11-10
FDA Drug
Yes

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06041438 on ClinicalTrials.gov