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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05567367




Registration number
NCT05567367
Ethics application status
Date submitted
4/04/2022
Date registered
5/10/2022
Date last updated
3/11/2022

Titles & IDs
Public title
A Healthy Volunteer Study Evaluating the the Safety, Tolerability, and Pharmacokinetics of RT234
Scientific title
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
Secondary ID [1] 0 0
ACTRN12618001077257
Secondary ID [2] 0 0
RT234-CL101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Combination Product - Drug: RT234 - vardenafil inhalation powder; Device: RS01 dry powder inhaler (RS01 DPI)
Treatment: Drugs - Vardenafil Oral Tablet

Experimental: RT234 0.2 mg, Single Ascending Dose (SAD) - Part 1, SAD Cohort 1A

Experimental: RT234 0.6 mg followed by oral vardenafil 20mg on day 3, SAD - Part 1, SAD Cohort 2A1

Experimental: Oral vardenafil 20mg followed by RT234 0.6 mg on day 3, SAD - Part 1, SAD Cohort 2A2

Experimental: RT234 1.2 mg, SAD - Part 1, SAD Cohort 3A

Experimental: RT234 2.4 mg, SAD - Part 1, SAD Cohort 4A

Experimental: RT234 2.4 mg, Multiple Ascending Dose (MAD) - Part 2, MAD Cohort 1B


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.

Treatment: Drugs: Vardenafil Oral Tablet
20 mg oral vardenafil tablet.
Intervention code [1] 0 0
Combination Product
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment related adverse events as assessed by CTCAE v5.0
Timepoint [1] 0 0
Up to to 10 days
Secondary outcome [1] 0 0
Peak plasma concentration (Cmax)
Timepoint [1] 0 0
Up to 10 days
Secondary outcome [2] 0 0
Time to reach maximum concentration (Tmax)
Timepoint [2] 0 0
Up to 10 days
Secondary outcome [3] 0 0
Area under the curve (AUC)
Timepoint [3] 0 0
Up to 10 days
Secondary outcome [4] 0 0
Half life (t1/2)
Timepoint [4] 0 0
Up to 10 days
Secondary outcome [5] 0 0
Terminal elimination rate constant (Kel)
Timepoint [5] 0 0
Up to 10 days
Secondary outcome [6] 0 0
Total body clearance (CL/F)
Timepoint [6] 0 0
Up to 10 days
Secondary outcome [7] 0 0
Total volume of distribution at the terminal phase
Timepoint [7] 0 0
Up to 10 days

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/12/2019
Sample size
Target
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network, Burnet Institute - Prahran
Recruitment postcode(s) [1] 0 0
3004 - Prahran

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Respira Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT05567367
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Donna Jarlenski, MS
Address 0 0
Respira Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries