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A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 706321 in the Blood

NCT04714073 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-09-12

Study results available
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Summary

To investigate the pharmacokinetics of a single oral dose of BI 706321 when given alone or in combination with itraconazole.

Conditions

  • Healthy

Interventions

DRUG

BI 706321

Treatment period 1: Single oral dose of 1 film-coated tablet administered with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) Treatment period 2: On day 1 of period 2 (1 h after the itraconazole administration) a single oral dose of 1 film-coated tablet administered with 240 mL of water after an overnight fast of at least 10 h.

DRUG

Itraconazole

Treatment period 2: Administered as an oral solution formulation once daily for 14 days orally with 240 mL of water after an overnight fast of at least 9 h, starting from day -3 up to day 11 of period 2.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-02-11
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • Germany

Study Locations

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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 NCT04714073 on ClinicalTrials.gov