Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 11:09 PM
Study NCT ID:
NCT05567367
Status:
COMPLETED
Last Update Posted:
2025-09-22
First Post:
2022-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Healthy Volunteer Study Evaluating the the Safety, Tolerability, and Pharmacokinetics of RT234
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}, {'id': 'D065627', 'term': 'Familial Primary Pulmonary Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}], 'ancestors': [{'id': 'D006973', 'term': 'Hypertension'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069058', 'term': 'Vardenafil Dihydrochloride'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2022-04-04', 'studyFirstSubmitQcDate': '2022-10-02', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment related adverse events as assessed by CTCAE v5.0', 'timeFrame': 'Up to to 10 days', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Peak plasma concentration (Cmax)', 'timeFrame': 'Up to 10 days', 'description': 'Cmax was measured for 4 single doses of oral vardenafil.'}, {'measure': 'Time to reach maximum concentration (Tmax)', 'timeFrame': 'Up to 10 days', 'description': 'Tmax was measured for 4 single doses of oral vardenafil.'}, {'measure': 'Area under the curve (AUC)', 'timeFrame': 'Up to 10 days', 'description': 'AUC was measured for 4 single doses of RT234'}, {'measure': 'Half life (t1/2)', 'timeFrame': 'Up to 10 days', 'description': 't1/2 was measured for 4 single doses of RT234'}, {'measure': 'Terminal elimination rate constant (Kel)', 'timeFrame': 'Up to 10 days', 'description': 'Kel was measured for 4 single doses of RT234'}, {'measure': 'Total body clearance (CL/F)', 'timeFrame': 'Up to 10 days', 'description': 'CL/F was measured for 4 single doses of RT234'}, {'measure': 'Total volume of distribution at the terminal phase', 'timeFrame': 'Up to 10 days', 'description': 'measured for 4 single doses of RT234'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'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'], 'conditions': ['Healthy Volunteer']}, 'referencesModule': {'references': [{'pmid': '33325799', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this two part study was to demonstrate safety, tolerability, and pharmacokinetics of RT234 in healthy volunteers.\n\nThis study is also known as Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 1 (VIPAH-PRN 1) study', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy male or female, 18 to 45 years of age (inclusive at time of informed consent)\n2. Normal heart, lung, kidney, and liver function based on physical examination\n3. 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\n4. A body mass index (BMI) of ≤18 to ≥30 kg/m2 at Screening\n5. 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)\n\nExclusion Criteria:\n\n1. 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\n2. 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.\n3. History of hypotension including fainting, syncope, orthostatic hypotension, and/or vasovagal reactions\n4. History of retinitis pigmentosa\n5. Vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION) or other optic perfusion impairment\n6. History of priapism or anatomical deformation of the penis\n7. History of sudden sensorineural hearing loss (SSHL), need for hearing aids, and/or other documented hearing loss\n8. A corrected QT interval using Fridericia's formula (QTcF) \\>450 msec\n9. Has evidence of significant obstructive lung disease on spirometry. Subjects with any of the following criteria will be excluded:\n\n 1. FEV1 \\<60% (predicted) (pre-bronchodilators); or\n 2. FEV1/FVC \\<65% (pre-bronchodilators)"}, 'identificationModule': {'nctId': 'NCT05567367', 'briefTitle': 'A Healthy Volunteer Study Evaluating the the Safety, Tolerability, and Pharmacokinetics of RT234', 'organization': {'class': 'INDUSTRY', 'fullName': 'Respira Therapeutics, Inc.'}, 'officialTitle': 'A Phase 1, Two-Part, Single-Center, Open-Label, Randomized, Cross-Over, Single Ascending Doses (SAD), Followed by a Multiple Ascending Doses (MAD) Safety and Pharmacokinetic Study of RT234 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'RT234-CL101'}, 'secondaryIdInfos': [{'id': 'ACTRN12618001077257', 'type': 'REGISTRY', 'domain': 'Australian New Zealand Clinical Trials Registry (ANZCTR)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RT234 0.2 mg, Single Ascending Dose (SAD)', 'description': 'Part 1, SAD Cohort 1A', 'interventionNames': ['Combination Product: Drug: RT234 - vardenafil inhalation powder; Device: RS01 dry powder inhaler (RS01 DPI)']}, {'type': 'EXPERIMENTAL', 'label': 'RT234 0.6 mg followed by oral vardenafil 20mg on day 3, SAD', 'description': 'Part 1, SAD Cohort 2A1', 'interventionNames': ['Combination Product: Drug: RT234 - vardenafil inhalation powder; Device: RS01 dry powder inhaler (RS01 DPI)', 'Drug: Vardenafil Oral Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Oral vardenafil 20mg followed by RT234 0.6 mg on day 3, SAD', 'description': 'Part 1, SAD Cohort 2A2', 'interventionNames': ['Combination Product: Drug: RT234 - vardenafil inhalation powder; Device: RS01 dry powder inhaler (RS01 DPI)', 'Drug: Vardenafil Oral Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'RT234 1.2 mg, SAD', 'description': 'Part 1, SAD Cohort 3A', 'interventionNames': ['Combination Product: Drug: RT234 - vardenafil inhalation powder; Device: RS01 dry powder inhaler (RS01 DPI)']}, {'type': 'EXPERIMENTAL', 'label': 'RT234 2.4 mg, SAD', 'description': 'Part 1, SAD Cohort 4A', 'interventionNames': ['Combination Product: Drug: RT234 - vardenafil inhalation powder; Device: RS01 dry powder inhaler (RS01 DPI)']}, {'type': 'EXPERIMENTAL', 'label': 'RT234 2.4 mg, Multiple Ascending Dose (MAD)', 'description': 'Part 2, MAD Cohort 1B', 'interventionNames': ['Combination Product: Drug: RT234 - vardenafil inhalation powder; Device: RS01 dry powder inhaler (RS01 DPI)']}], 'interventions': [{'name': 'Drug: RT234 - vardenafil inhalation powder; Device: RS01 dry powder inhaler (RS01 DPI)', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['vardenafil inhalation powder'], 'description': 'RT234 is a drug/device combination product composed of vardenafil hydrochloride as the drug constituent and will utilize RS01 DPI device.', 'armGroupLabels': ['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']}, {'name': 'Vardenafil Oral Tablet', 'type': 'DRUG', 'otherNames': ['Levitra'], 'description': '20 mg oral vardenafil tablet.', 'armGroupLabels': ['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']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Prahran', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Nucleus Network, Burnet Institute', 'geoPoint': {'lat': -37.85114, 'lon': 144.99318}}], 'overallOfficials': [{'name': 'Donna Jarlenski, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Respira Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Respira Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}