A Phase I, single dose, open, two-way crossover blood level study of vardenafil blood levels administered as LEVITRA 10mg oral tablets verses a single dose of vardenafil aqueous solution administered to healthy volunteers by inhalation using the IMT nebuliser

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12607000008426
• Date of registration: 08/01/2007
• Prospective Registration: Yes
• Primary sponsor: Intelligent Medical Technologies Pty. ltd.(IMT)
• Public title: A Phase I, single dose, open, two-way crossover blood level study of vardenafil blood levels administered as LEVITRA 10mg oral tablets verses a single dose of vardenafil aqueous solution administered to healthy volunteers by inhalation using the IMT nebuliser
• Scientific title: A Phase I, single dose, open, two-way crossover blood level study of vardenafil blood levels administered as LEVITRA 10mg oral tablets verses a single dose of vardenafil aqueous solution administered to healthy volunteers by inhalation using the IMT nebuliser
• Date of first enrolment: 01/02/2007
• Target sample size: 12
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12607000008426.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Crossover;Type of endpoint: Pharmacokinetics / pharmacodynamics;
• Phase: Phase 1

Countries of recruitment

Australia

Contacts

• Name: Dr. Phillip Altman

• Name: Dr. Wayne Hooper

Key inclusion & exclusion criteria

Inclusion criteria: Able to provide written informed consentAble to comply with the requirements of the studyAble to provide a permanent residential addressJudged as healthy by medical history, physical examination, an electrocardiogram (ECG) and laboratory screening within 28 days of study entryTest negative for hepatitis B and CNo evidence of drug or alcohol abuseWilling to abstain from taking any prescription or over-the-counter medication while in the clinical trial – all health supplements will be discontinued at least 7 days before the first treatmentAble to demonstrate “comfortable cooperation” with nebulized administration of water using the IMT nebuliser
Exclusion criteria: Recent (within the last 12 months) serious medical illness or medical disorderHistory of cardiovascular diseaseAanatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease) or who have conditions which may predispose them to priapismKnown hereditary degenerative retinal disorders such as retinitis pigmentosa.Bleeding disorders or significant active peptic ulcerationSubject currently taking prescription medications of any typeIngestion of any vardenafil or related drugs in the 4 weeks prior to the day set for the Period 1 dose or during the study itself.· Ingestion of any other drug, including St John’s Wort, in the week prior to dosing or during the study itself which, in the opinion of the Medical Investigator, could compromise the study e.g. through pharmacokinetic or metabolic interactions, or analytical interference or provide a risk to the subjectCurrent infectionAbnormal findings on physical examinationPresence of any clinically significant abnormality in the ECGAbnormal screening laboratory values considered clinically significant by the investigatorDonation of blood within the last 60 daysParticipation in another clinical trial within the last 30 daysHistory of alcohol or drug abusesmokers or former smokers who have smoked within the immediately preceding 6 monthsIngestion of any alcohol, xanthines (i.e. tea, coffee, cola drinks, or chocolate) or grapefruit containing foods or beverages within the 24 hours prior to and the first 6 or 14 hours after dosing (in the dose-ranging and comparative pharmacokinetic studies respectively).Failure to conform to the requirements of the protocol.Detection of any of the proscribed drugs in the urine drug screenVital signs outside the reference range and clinically significantUrinalysis result outside the reference range and clinically significantSubjects with a history of asthma will be excluded. If Forced expiratory volume (FEV1) , forced expiratory volume (FVC) or FEV1 / FVC ratio is outside the normal range, the subject will be excluded.

Age minimum: 18 Years
Age maximum: 55 Years
Gender: Males

Health Condition(s) or Problem(s) studied

Blood - Normal development and function of platelets and erythrocytes

Blood levels of vardenafil in healthy male volunteers;
Blood levels of vardenafil in healthy male volunteers

Intervention(s)

A single dose of Levitra, vardenafil hydrochloride (HCl), 10mg oral tablets or vardenafil HCl administered using a nebuliser solution containing 10mg/mL vardenafil HCl via inhalation commencing with a dose of 0.015mg vardenafil. A one week washout period will apply between comparator doses.

Primary Outcome(s)

Blood level vs time[At 0, 5, 10, 15, 30, 45 minutes, and at 1, 1.5, 2, 2.5, 3, 4, 6, 8 10, 12 and 14 hours post dose.]

Secondary Outcome(s)

Respiratory tolerance[Predose, 15, 30min, 1, 2, 4, 6, 8, 12, 14h.]

Secondary ID(s)

Intelligent Medical Technologies Pty Ltd (IMT): IMT/VAR/001

Source(s) of Monetary Support

Intelligent Medical Technologies Pty. Ltd.

Ethics review

Status: Approved
Approval date:
Contact:

Queensland Institute of Medical Research HREC-Royal Brisbane Hospital