Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Inhaled ED drug tested for safety in healthy people

NCT ID NCT05567367

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early-phase trial tested the safety and how the body processes an inhaled form of vardenafil (RT234) in 31 healthy adults. Participants received single and multiple doses of the drug via an inhaler or as a pill. The study is complete and focused on side effects and drug levels, not on treating any disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RT234 (vardenafil inhalation powder)

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

31 people

The number who actually took part.

Started

Jul 2018

Finished

Dec 2019

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Healthy male or female, 18 to 45 years of age (inclusive at time of informed consent) 2. Normal heart, lung, kidney, and liver function based on physical examination 3. 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 4. A body mass index (BMI) of ≤18 to ≥30 kg/m2 at Screening 5. 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) Exclusion Criteria: 1. 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 2. 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. 3. History of hypotension including fainting, syncope, orthostatic hypotension, and/or vasovagal reactions 4. History of retinitis pigmentosa 5. Vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION) or other optic perfusion impairment 6. History of priapism or anatomical deformation of the penis 7. History of sudden sensorineural hearing loss (SSHL), need for hearing aids, and/or other documented hearing loss 8. A corrected QT interval using Fridericia's formula (QTcF) \>450 msec 9. Has evidence of significant obstructive lung disease on spirometry. Subjects with any of the following criteria will be excluded: 1. FEV1 \<60% (predicted) (pre-bronchodilators); or 2. FEV1/FVC \<65% (pre-bronchodilators)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Healthy volunteer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Nucleus Network, Burnet Institute

    Prahran, Victoria, 3004, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.