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| ID | Type | Description | Link |
|---|---|---|---|
| ACTRN12618001077257 | Registry Identifier | Australian New Zealand Clinical Trials Registry (ANZCTR) |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RT234 0.2 mg, Single Ascending Dose (SAD) | Experimental | Part 1, SAD Cohort 1A |
|
| RT234 0.6 mg followed by oral vardenafil 20mg on day 3, SAD | Experimental | Part 1, SAD Cohort 2A1 |
|
| Oral vardenafil 20mg followed by RT234 0.6 mg on day 3, SAD | Experimental | Part 1, SAD Cohort 2A2 |
|
| RT234 1.2 mg, SAD | Experimental | Part 1, SAD Cohort 3A |
|
| RT234 2.4 mg, SAD | Experimental | Part 1, SAD Cohort 4A |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cmax) | Cmax was measured for 4 single doses of oral vardenafil. | Up to 10 days |
| Time to reach maximum concentration (Tmax) | Tmax was measured for 4 single doses of oral vardenafil. |
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Inclusion Criteria:
Exclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Donna Jarlenski, MS | Respira Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network, Burnet Institute | Prahran | Victoria | 3004 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33325799 | Result | 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. |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| D065627 | Familial Primary Pulmonary Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| ID | Term |
|---|---|
| D006973 | Hypertension |
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| ID | Term |
|---|---|
| D000069058 | Vardenafil Dihydrochloride |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| RT234 2.4 mg, Multiple Ascending Dose (MAD) | Experimental | Part 2, MAD Cohort 1B |
|
|
| Vardenafil Oral Tablet | Drug | 20 mg oral vardenafil tablet. |
|
|
| Up to 10 days |
| Area under the curve (AUC) | AUC was measured for 4 single doses of RT234 | Up to 10 days |
| Half life (t1/2) | t1/2 was measured for 4 single doses of RT234 | Up to 10 days |
| Terminal elimination rate constant (Kel) | Kel was measured for 4 single doses of RT234 | Up to 10 days |
| Total body clearance (CL/F) | CL/F was measured for 4 single doses of RT234 | Up to 10 days |
| Total volume of distribution at the terminal phase | measured for 4 single doses of RT234 | Up to 10 days |
| D010879 |
| Piperazines |