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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
RT234 is a drug/device combination product composed of vardenafil hydrochloride as the drug constituent and will utilize RS01 DPI device.
20 mg oral vardenafil tablet.
Nucleus Network, Burnet Institute
Prahran, Victoria, Australia
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.
Time frame: Up to to 10 days
Peak plasma concentration (Cmax)
Cmax was measured for 4 single doses of oral vardenafil.
Time frame: Up to 10 days
Time to reach maximum concentration (Tmax)
Tmax was measured for 4 single doses of oral vardenafil.
Time frame: Up to 10 days
Area under the curve (AUC)
AUC was measured for 4 single doses of RT234
Time frame: Up to 10 days
Half life (t1/2)
t1/2 was measured for 4 single doses of RT234
Time frame: Up to 10 days
Terminal elimination rate constant (Kel)
Kel was measured for 4 single doses of RT234
Time frame: Up to 10 days
Total body clearance (CL/F)
CL/F was measured for 4 single doses of RT234
Time frame: Up to 10 days
Total volume of distribution at the terminal phase
measured for 4 single doses of RT234
Time frame: Up to 10 days
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