Multiple Rising Oral Doses of BI 1060469 in Healthy Subjects and Mild Asthma Patients

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: BI 1060469 Healthy; Drug: Placebo to BI 1060469; Drug: BI 1060469 asthmatics; Drug: Placebo to BI 1060469 asthmatics

• Registration Number: NCT02126865
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective of this trial is to investigate the safety and tolerability of BI 1060469 in healthy male and female subjects after oral administration of repeated rising doses of 3 mg, 10 mg, 25 mg, 75 mg, 150 mg and 250 mg qd. of 1 day followed by 14 days and in asthmatic male and female patients after oral administration of repeated rising doses of 25 mg and 150 mg qd of 1 day followed by 28 days.

Secondary objectives are the exploration of the pharmacokinetics (PK) including dose proportionality, dose linearity after single and multiple dose segments, pharmacodynamics (PD) of BI 1060469 and to describe the PK/PD relationship.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-28
• Study First Submitted QC: 2014-04-28
• Study First Posted: 2014-04-30
• Study Start: 2014-05
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-12
• Last Update Posted: 2015-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 1060469 Healthy	BI 1060469 Healthy	Multiple rising dose qd for 15 days
Placebo to BI 1060469	Placebo to BI 1060469	Matching placebo as tablet for 15 days
BI 1060469 asthmatics	BI 1060469 asthmatics	Multiple rising dose qd for 29 days
Placebo to BI 1060469 asthmatics	Placebo to BI 1060469 asthmatics	Matching placebo as tablet for 29 days

Primary Outcome Measures

Name	Time	Method
Percentage (%) of subjects with drug-related adverse events (AEs)	Day 1 to 29 or Day 1 to Day 43 (end of trial)

Secondary Outcome Measures

Name	Time	Method
AUCt,ss (area under the concentration-time curve of BI 1060469 in plasma at steady state over a uniform dosing interval t)	0 to 672 hours or 0 to 1008 hours
Cpre,N (predose concentration of BI 1060469 in plasma immediately before administration of the Nth dose after N-1 doses were administered)	0 to 672 hours or 0 to 1008 hours
AUCt,1 (area under the concentration-time curve of BI 1060469 in plasma over a uniform dosing interval t after administration of the first dose)	0 to 672 hours or 0 to 1008 hours
AUC0-infinity (area under the concentration-time curve of BI 1060469 in plasma over the time interval from 0 extrapolated to infinity)	0 to 672 hours or 0 to 1008 hours
Cmax (maximum measured concentration of BI 1060469 in plasma)	0 to 672 hours or 0 to 1008 hours
Cmax,ss (maximum measured concentration of BI 1060469 in plasma at steady state)	0 to 672 hours or 0 to 1008 hours
Linearity index (LI)	0 to 672 hours or 0 to 1008 hours

Trial Locations

Locations (1)

1333.2.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Berlin, Germany