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

NCT05567367 | Completed Phase 1 FDA Drug FDA Device

• 2 other identifiers: RT234-CL101ACTRN12618001077257
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Vascular Diseases; Cardiovascular Diseases; Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Vardenafil Dihydrochloride; Inhaled Vardenafil; Vasodilator Agents; Phosphodiesterase 5 Inhibitors; Phosphodiesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment related adverse events as assessed by CTCAE v5.0

  Adverse events reported by participants and those observed by the investigator in relation to laboratory tests, vital signs, ECGs, medications used to treat adverse events, and physical examinations were analyzed.

  Up to to 10 days

Secondary Outcomes (7)

• Peak plasma concentration (Cmax)

  Up to 10 days

• Time to reach maximum concentration (Tmax)

  Up to 10 days

• Area under the curve (AUC)

  Up to 10 days

• Half life (t1/2)

  Up to 10 days

• Terminal elimination rate constant (Kel)

  Up to 10 days

Study Arms (6)

RT234 0.2 mg, Single Ascending Dose (SAD)

EXPERIMENTAL

Part 1, SAD Cohort 1A

Combination Product: Drug: RT234 - vardenafil inhalation powder; Device: RS01 dry powder inhaler (RS01 DPI)

RT234 0.6 mg followed by oral vardenafil 20mg on day 3, SAD

EXPERIMENTAL

Part 1, SAD Cohort 2A1

Combination Product: Drug: RT234 - vardenafil inhalation powder; Device: RS01 dry powder inhaler (RS01 DPI); Drug: Vardenafil Oral Tablet

Oral vardenafil 20mg followed by RT234 0.6 mg on day 3, SAD

EXPERIMENTAL

Part 1, SAD Cohort 2A2

Combination Product: Drug: RT234 - vardenafil inhalation powder; Device: RS01 dry powder inhaler (RS01 DPI); Drug: Vardenafil Oral Tablet

RT234 1.2 mg, SAD

EXPERIMENTAL

Part 1, SAD Cohort 3A

Combination Product: Drug: RT234 - vardenafil inhalation powder; Device: RS01 dry powder inhaler (RS01 DPI)

RT234 2.4 mg, SAD

EXPERIMENTAL

Part 1, SAD Cohort 4A

Combination Product: Drug: RT234 - vardenafil inhalation powder; Device: RS01 dry powder inhaler (RS01 DPI)

RT234 2.4 mg, Multiple Ascending Dose (MAD)

EXPERIMENTAL

Part 2, MAD Cohort 1B

Combination Product: Drug: RT234 - vardenafil inhalation powder; Device: RS01 dry powder inhaler (RS01 DPI)

Interventions

Drug: RT234 - vardenafil inhalation powder; Device: RS01 dry powder inhaler (RS01 DPI) COMBINATION_PRODUCT

RT234 is a drug/device combination product composed of vardenafil hydrochloride as the drug constituent and will utilize RS01 DPI device.

Also known as: vardenafil inhalation powder

Oral vardenafil 20mg followed by RT234 0.6 mg on day 3, SAD; RT234 0.2 mg, Single Ascending Dose (SAD); RT234 0.6 mg followed by oral vardenafil 20mg on day 3, SAD; RT234 1.2 mg, SAD; RT234 2.4 mg, Multiple Ascending Dose (MAD); RT234 2.4 mg, SAD

Vardenafil Oral Tablet DRUG

20 mg oral vardenafil tablet.

Also known as: Levitra

Oral vardenafil 20mg followed by RT234 0.6 mg on day 3, SAD; RT234 0.6 mg followed by oral vardenafil 20mg on day 3, SAD

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female, 18 to 45 years of age (inclusive at time of informed consent)
• Normal heart, lung, kidney, and liver function based on physical examination
• Systolic blood pressure of 100-145 mmHg, diastolic blood pressure of 50-90 mmHg, and a resting heart rate of 40-100 bpm at Screening
• A body mass index (BMI) of ≤18 to ≥30 kg/m2 at Screening
• Must be a non-smoker or ex-smoker with less than a 5-pack year history of smoking (including the use of electronic cigarettes) and have ceased smoking ≥1 year prior to Screening; or a social smoker (defined as less than 10 cigarettes in the previous 12 months)

You may not qualify if:

• Has serum transaminase (i.e., alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], or gamma-glutamyl transferase \[GGT\]) levels greater than three times the upper level of normal
• Abnormal orthostatic vital signs (at screening) defined as a decrease of ≥20 mmHg in systolic blood pressure and/or a decrease of ≥10 mmHg in diastolic blood pressure and/or \>25 bpm increase in heart rate within 3 minutes of standing, or with symptoms of light-headedness, dizziness, or fainting upon standing.
• History of hypotension including fainting, syncope, orthostatic hypotension, and/or vasovagal reactions
• History of retinitis pigmentosa
• Vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION) or other optic perfusion impairment
• History of priapism or anatomical deformation of the penis
• History of sudden sensorineural hearing loss (SSHL), need for hearing aids, and/or other documented hearing loss
• A corrected QT interval using Fridericia's formula (QTcF) \>450 msec
• Has evidence of significant obstructive lung disease on spirometry. Subjects with any of the following criteria will be excluded:
• FEV1 \<60% (predicted) (pre-bronchodilators); or
• FEV1/FVC \<65% (pre-bronchodilators)

Sponsors & Collaborators

• Respira Therapeutics, Inc.: lead

Study Sites (1)

Nucleus Network, Burnet Institute

Prahran, Victoria, 3004, Australia

Location

Related Publications (1)

• 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.

  PMID: 33325799 BACKGROUND

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Vascular Diseases; Cardiovascular Diseases; Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Interventions

Vardenafil Dihydrochloride

Condition Hierarchy (Ancestors)

Hypertension

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Donna Jarlenski, MS

  Respira Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: October 5, 2022
• Study Start: July 31, 2018
• Primary Completion: December 4, 2019
• Study Completion: December 4, 2019
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)