CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 14 enrolled
Drug / intervention
BI 706321 +1 moredrug
Likely dose
BI 706321 240 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04714073
NCT04714073Phase 1Completed
CompareCT.gov

Effect of Itraconazole on the Pharmacokinetics of a Single Oral Dose of BI 706321 in Healthy Male Subjects (an Open-label, Two-period Fixed Sequence Design Study)

Boehringer Ingelheim·interventional·Posted Jan 19, 2021·Updated Sep 12, 2025

In Brief

A Phase 1 clinical trial evaluating BI 706321 and Itraconazole for Healthy. Completed, enrolled 14 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedJan 19, 2021
Enrollment StartFeb 11, 2021
Primary CompletionApr 30, 2021
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 5.5 years ago

Interventions

BI 706321drug

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.

Itraconazoledrug

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.