NCT03971539

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

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).

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	BI 894416	BI 894416 film-coated tablet.
DRUG	Placebo	Placebo film-coated tablet matching BI 894416.

Timeline

• Start date: 2019-07-15
• Primary completion: 2020-10-26
• Completion: 2020-10-26
• First posted: 2019-06-03
• Last updated: 2023-08-21
• Results posted: 2023-08-21

Locations

1 site across 1 country: Germany