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

NCT05567367 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2025-09-22

No results posted yet for this study

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

Conditions

  • Healthy Volunteer

Interventions

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.

Sponsors & Collaborators

  • Respira Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Donna Jarlenski, MS · Respira Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-31
Primary Completion
2019-12-04
Completion
2019-12-04
FDA Drug
Yes
FDA Device
Yes

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05567367 on ClinicalTrials.gov