A Healthy Volunteer Study Evaluating the the Safety, Tolerability, and Pharmacokinetics of RT234

Phase 1 Completed 31 enrolled Respira Therapeutics, Inc.

RandomizedParallel-groupOpen-labelTreatment

Summary

The objective of this two part study was to demonstrate safety, tolerability, and pharmacokinetics of RT234 in healthy volunteers. This study is also known as Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 1 (VIPAH-PRN 1) study

Timeline

Start: 2018-07-31
Primary completion: 2019-12-04
Completion: 2019-12-04

Publications

Results Eldon MA, Parsley EL, Maurer M, Tarara TE, Okikawa J, Weers JG. Safety, Tolerability, and Pharmacokinetics of RT234 (Vardenafil Inhalation Powder): A First-in-Human, Ascending Single- and Multiple-Dose Study in Healthy Subjects. J Aerosol Med Pulm Drug Deliv. 2021 Aug;34(4):251-261. doi: 10.1089/jamp.2020.1651. Epub 2020 Dec 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vardenafil	Small molecule	0.2 mg	Inhaled
Subject	Vardenafil	Small molecule	0.6 mg	Inhaled
Subject	Vardenafil	Small molecule	1.2 mg	Inhaled
Subject	Vardenafil	Small molecule	2.4 mg	Inhaled
Subject	Vardenafil	Small molecule	20 mg	Inhaled

Indications

No indication recorded.