NCT05567367

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

A Phase 1, Two-Part, Single-Center, Open-Label, Randomized, Cross-Over, Single Ascending Doses (SAD), Followed by a Multiple Ascending Doses (MAD) Safety and Pharmacokinetic Study of RT234 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Respira Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Detailed description

This study was designed to evaluate safety and tolerability and to characterize the PK profiles of single and repeated doses of inhaled vardenafil as RT234. In addition, vardenafil PK after single 0.6 mg doses of RT234 was compared to that following administration of a single 20 mg dose of oral vardenafil tablets.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Drug: RT234 - vardenafil inhalation powder; Device: RS01 dry powder inhaler (RS01 DPI)	RT234 is a drug/device combination product composed of vardenafil hydrochloride as the drug constituent and will utilize RS01 DPI device.
DRUG	Vardenafil Oral Tablet	20 mg oral vardenafil tablet.

Timeline

• Start date: 2018-07-31
• Primary completion: 2019-12-04
• Completion: 2019-12-04
• First posted: 2022-10-05
• Last updated: 2025-09-22

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study
• FDA-regulated device study