Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of a Single Oral Dose of BI 1026706 in Healthy Male Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 1026706; Drug: Itraconazole

• Registration Number: NCT02513446
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective of this trial is to investigate the effect of multiple doses of itraconazole on the pharmacokinetics of BI 1026706 given as single dose. The assessment of safety and tolerability of BI 1026706 is an additional objective of this trial. Furthermore, the pharmacokinetics of the metabolite BI 1072668 will be explored.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-30
• Study First Submitted QC: 2015-07-30
• Study First Posted: 2015-07-31
• Study Start: 2015-09-29
• Primary Completion: 2015-11-14
• Study Completion: 2015-11-20
• Status Verified: 2018-12
• Results First Submitted: 2018-12-12
• Results First Submitted QC: 2018-12-12
• Last Update Submitted: 2018-12-12
• Results First Posted: 2019-03-29
• Last Update Posted: 2019-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BI 1026706	BI 1026706	Single dose
BI 1026706 + Itraconazole	BI 1026706	7 days of itraconazole treatment combined with a single dose of 1026706 on day 4
BI 1026706 + Itraconazole	Itraconazole	7 days of itraconazole treatment combined with a single dose of 1026706 on day 4

Primary Outcome Measures

Name	Time	Method
Area Under the Curve of BI 1026706 From 0 to the Last Quantifiable Data Point (AUC0-tz)	-3 hours (h) before drug administration and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administration	Area under the concentration-time curve of BI 1026706 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Maximum Concentration of BI 1026706 (Cmax)	0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administration	Maximum measured concentration of BI 1026706 in plasma (Cmax)

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve of BI 1026706 From 0 Extrapolated to Infinity (AUC0-inf)	-3 hours (h) before drug administration and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administration	Area under the concentration-time curve of BI 1026706 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)

Trial Locations

Locations (1)

1320.20.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany