A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1291583 in the Blood

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 1291583; Drug: Itraconazole

• Registration Number: NCT03890887
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The main objective of this trial is to investigate the relative bioavailability of BI 1291583 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-25
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-26
• Study Start: 2019-04-12
• Primary Completion: 2019-07-29
• Study Completion: 2019-07-29
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-09
• Last Update Posted: 2021-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
All subjects: Reference followed by Test treatments	Itraconazole	Reference - BI 1291583 alone. Test - BI 1291583 + Itraconazole
All subjects: Reference followed by Test treatments	BI 1291583	Reference - BI 1291583 alone. Test - BI 1291583 + Itraconazole

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of BI 1291583 in plasma over the time interval from 0 to the last quantifiable data point	Up to 263 hours.
Maximum measured concentration of BI 1291583 in plasma	Up to 263 hours.

Secondary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity	Up to 263 hours.

Trial Locations

Locations (1)

CRS Clinical Research Services Mannheim GmbH; 🇩🇪 Mannheim, Germany