Inhaled ED drug tested for safety in healthy people
NCT ID NCT05567367
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 Hide 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)
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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
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