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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-31

Study Completion Date

2019-12-04

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RT234 0.2 mg, Single Ascending Dose (SAD)

Part 1, SAD Cohort 1A

Group Type EXPERIMENTAL

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

Intervention Type COMBINATION_PRODUCT

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

RT234 0.6 mg followed by oral vardenafil 20mg on day 3, SAD

Part 1, SAD Cohort 2A1

Group Type EXPERIMENTAL

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

Intervention Type COMBINATION_PRODUCT

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

Vardenafil Oral Tablet

Intervention Type DRUG

20 mg oral vardenafil tablet.

Oral vardenafil 20mg followed by RT234 0.6 mg on day 3, SAD

Part 1, SAD Cohort 2A2

Group Type EXPERIMENTAL

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

Intervention Type COMBINATION_PRODUCT

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

Vardenafil Oral Tablet

Intervention Type DRUG

20 mg oral vardenafil tablet.

RT234 1.2 mg, SAD

Part 1, SAD Cohort 3A

Group Type EXPERIMENTAL

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

Intervention Type COMBINATION_PRODUCT

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

RT234 2.4 mg, SAD

Part 1, SAD Cohort 4A

Group Type EXPERIMENTAL

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

Intervention Type COMBINATION_PRODUCT

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

RT234 2.4 mg, Multiple Ascending Dose (MAD)

Part 2, MAD Cohort 1B

Group Type EXPERIMENTAL

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

Intervention Type COMBINATION_PRODUCT

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

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

Vardenafil Oral Tablet

20 mg oral vardenafil tablet.

Intervention Type DRUG

Other Intervention Names

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vardenafil inhalation powder Levitra

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes