First clinical trials of the inhaled epithelial sodium channel inhibitor BI 1265162 in healthy volunteers.

ABSTRACT:

Background

Inhibition of the epithelial sodium channel (ENaC) represents a mutation-agnostic therapeutic approach to restore airway surface liquid hydration and mucociliary clearance in patients with cystic fibrosis. BI 1265162 is an inhaled ENaC inhibitor with demonstrated preclinical efficacy.

Methods

Three phase I trials of BI 1265162 in healthy male subjects are presented: NCT03349723 (single-rising-dose trial evaluating safety, tolerability and pharmacokinetics (PK)); NCT03576144 (multiple-rising-dose trial evaluating safety, tolerability and PK); and NCT03907280 (absolute bioavailability trial).

Results

BI 1265162 single doses ≤1200 µg and multiple doses of 600 µg were well tolerated. Adverse events were balanced across treatment groups, were of mainly mild or m

SUBMITTER: Mackie A 

PROVIDER: S-EPMC7861022 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature