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A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1815368 in the Blood

NCT05965583 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-05-12

Study results available
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Summary

The main objective of this trial is to investigate the effect on the exposure of BI 1815368 in plasma when given as oral single dose together with multiple oral doses of itraconazole (Test, T) as compared to when given alone as oral single dose (Reference, R).

Conditions

  • Healthy

Interventions

DRUG

BI 1815368

BI 1815368

DRUG

Itraconazole

Itraconazole

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2023-08-02
Primary Completion
2023-10-24
Completion
2023-10-24
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 NCT05965583 on ClinicalTrials.gov