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Evaluation of Safety and Tolerability of BI 894416 in Patients With Mild Asthma

Asthma Clinical Trial

Official title:
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses and Multiple Rising Oral Doses of BI 894416 Versus Placebo in Male Patients With Asthma (Single-blind, Randomised, Placebo-controlled, Parallel Group Design).

Clinical Trial Summary

In both parts, the primary comparisons of interest are between the percentage of patients with drug-related adverse events at each dose and placebo during single and multiple dosing regimens. Based on these, the primary trial objective is to assess safety and tolerability of BI 894416 at each dose. Secondary measures of interest are the geometric means of BI 894416 plasma AUC0-∞ and Cmax after single dose in SRD part and AUC0-8 and Cmax after single dose as well as AUCτ,ss and Cmax,ss after 7 days multiple dosing in MRD part. The objective is to assess the pharmacokinetics of BI 894416 following single and multiple administration.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03971539
Study type Interventional
Source Boehringer Ingelheim
Contact
Status Completed
Phase Phase 1
Start date July 15, 2019
Completion date October 26, 2020
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