A Study in Healthy Men That Tests if Taking BI 1265162 by Mouth, Intravenously, or Inhaled Influences the Amount of BI 1265162 in the Blood

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 1265162 (T1); Drug: BI 1265162 (T2); Drug: BI 1265162 (R); Drug: BI 1265162 (T3)

• Registration Number: NCT03907280
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The main objective of this trial is to investigate the absolute bioavailability of BI 1265162 following administration of oral solution and inhaled (with and without charcoal) via Respimat.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-04-05
• Study First Submitted QC: 2019-04-05
• Study First Posted: 2019-04-08
• Study Start: 2019-04-23
• Primary Completion: 2019-12-06
• Study Completion: 2019-12-06
• Results First Submitted: 2021-12-17
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-16
• Last Update Submitted: 2022-03-16
• Results First Posted: 2022-07-06
• Last Update Posted: 2022-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
R-T1-T2-T3	BI 1265162 (R)	-
T2-R-T1-T3	BI 1265162 (T1)	-
T2-R-T1-T3	BI 1265162 (R)	-
T1-T2-R-T3	BI 1265162 (T2)	-
T1-T2-R-T3	BI 1265162 (R)	-
R-T1-T2-T3	BI 1265162 (T3)	-
T1-T2-R-T3	BI 1265162 (T1)	-
R-T1-T2-T3	BI 1265162 (T2)	-
T2-R-T1-T3	BI 1265162 (T2)	-
T2-R-T1-T3	BI 1265162 (T3)	-
T1-T2-R-T3	BI 1265162 (T3)	-
R-T1-T2-T3	BI 1265162 (T1)	-

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve of BI 1265162 in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Dose-normalized, (AUC0-∞, Norm)	Up to 24 hours following administration of the trial drug, see detailed time frame in the endpoint description.	Area under the concentration-time curve of BI 1265162 in plasma over the time interval from 0 extrapolated to infinity, dose-normalized to 1 µg BI 1265162, (AUC0-∞, norm).; Time frame for treatment T1: Within 3 hours before and 30 and 45 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours following administration of the trial drug.; Time frame for treatment T2 and T3: Within 3 hours before and 2, 5, 10, 15 and 40 minutes, 1, 2, 4, 8, 10, 12 and 24 hours following administration of the trial drug.; Time frame for treatment R: Within 3 hours (h) before and 5, 30 and 59 minutes (min), 1 h 5 min, 1 h 10 min, 1 h 20 min, 1 h 40 min, 2, 2 h 30 min, 3, 3 h 30 min, 4, 5, 7, 9, 11, 13 and 24 hours following administration of the trial drug.

Trial Locations

Locations (1)

Humanpharmakologisches Zentrum Biberach; 🇩🇪 Biberach, Germany