Interaction of BI 691751 With Itraconazole

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 691751; Drug: itraconazole

• Registration Number: NCT02044393
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Investigation of the relative bioavailability of a single dose of BI 691751 when given alone and together with itraconazole; safety and tolerability

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-22
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-24
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2015-11
• Results First Submitted: 2015-11-11
• Results First Submitted QC: 2015-11-11
• Last Update Submitted: 2015-11-11
• Results First Posted: 2015-12-16
• Last Update Posted: 2015-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reference	BI 691751	single dose BI 691751
Test	itraconazole	multiple doses of itraconazole + single dose BI 691751
Test	BI 691751	multiple doses of itraconazole + single dose BI 691751

Primary Outcome Measures

Name	Time	Method
AUC0-tz (Area Under the Concentration-time Curve of BI 691751 in Plasma and Whole Blood Over the Time Interval From 0 up to the Last Quantifiable Concentration)	from day 1 to 31 days postdose relative to BI 691751 administration (h:min): -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h.	AUC0-tz: area under the concentration-time curve of BI 691751 in plasma and whole blood over the time interval from 0 up to the last quantifiable concentration.
Cmax (Maximum Measured Concentration of BI 691751 in Plasma and Whole Blood)	From day 1 to 31 days postdose relative to BI 691751 administration (h:min): -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h.	Cmax (maximum measured concentration of BI 691751 in plasma and whole blood).

Secondary Outcome Measures

Name	Time	Method
AUC0-infinity (Area Under the Concentration-time Curve of BI 691751 in Plasma and Whole Blood Over the Time Interval From 0 Extrapolated to Infinity)	from day 1 to 31 days postdose relative to BI 691751 administration time: -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h.	AUC0-infinity (area under the concentration-time curve of BI 691751 in plasma and whole blood over the time interval from 0 extrapolated to infinity).

Trial Locations

Locations (1)

1334.10.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany