Trial | NCT05567367  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    31
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.
Study Started
Jul 31
2018
Primary Completion
Dec 04
2019
Study Completion
Dec 04
2019
Last Update
Nov 03
2022

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

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

  • Other names: vardenafil inhalation powder

Drug Vardenafil Oral Tablet

20 mg oral vardenafil tablet.

  • Other names: Levitra

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

RT234 2.4 mg, Multiple Ascending Dose (MAD) Experimental

Part 2, MAD Cohort 1B

Criteria 

Inclusion Criteria:

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)

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:

FEV1 <60% (predicted) (pre-bronchodilators); or
FEV1/FVC <65% (pre-bronchodilators)
No Results Posted