Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000008426
Ethics application status
Approved
Date submitted
18/12/2006
Date registered
8/01/2007
Date last updated
4/04/2008
Type of registration
Prospectively registered

Titles & IDs
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
Secondary ID [1] 326 0
Intelligent Medical Technologies Pty Ltd (IMT): IMT/VAR/001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood levels of vardenafil in healthy male volunteers 1511 0
Condition category
Condition code
Blood 1609 1609 0 0
Normal development and function of platelets and erythrocytes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 1318 0
Treatment: Drugs
Comparator / control treatment
Levitra 10mg tablets
Control group
Active

Outcomes
Primary outcome [1] 2218 0
Blood level vs time
Timepoint [1] 2218 0
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 [1] 3872 0
Respiratory tolerance
Timepoint [1] 3872 0
Predose, 15, 30min, 1, 2, 4, 6, 8, 12, 14h.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
No
Key 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.

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)
central randomisation by sealed envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Coin toss, blocking
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
one week washout period between treatments
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1753 0
Commercial sector/Industry
Name [1] 1753 0
Intelligent Medical Technologies Pty. Ltd.
Country [1] 1753 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Intelligent Medical Technologies Pty. ltd.(IMT)
Address
204 Botany Rd., Alexandria, NSW 2015 Australia
Country
Australia
Secondary sponsor category [1] 1554 0
None
Name [1] 1554 0
Nil
Address [1] 1554 0
Country [1] 1554 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3278 0
Queensland Institute of Medical Research HREC-Royal Brisbane Hospital
Ethics committee address [1] 3278 0
Ethics committee country [1] 3278 0
Australia
Date submitted for ethics approval [1] 3278 0
Approval date [1] 3278 0
24/03/2006
Ethics approval number [1] 3278 0
H0603-007T (P954)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27925 0
Address 27925 0
Country 27925 0
Phone 27925 0
Fax 27925 0
Email 27925 0
Contact person for public queries
Name 10507 0
Dr. Phillip Altman
Address 10507 0
Altman Biomedical Consulting Pty. Ltd.
152 Cammeray Rd.
Cammeray NSW 2062
Country 10507 0
Australia
Phone 10507 0
+61 2 99044489
Fax 10507 0
+61 2 99045109
Email 10507 0
pmaltman@bigpond.net.au
Contact person for scientific queries
Name 1435 0
Dr. Wayne Hooper
Address 1435 0
Q-Pharm
Level D, 300 C Hereston Rd,
Hereston, QLD 4006
Country 1435 0
Australia
Phone 1435 0
+61 7 38453636
Fax 1435 0
+61 7 38453637
Email 1435 0
w.hooper@qpharm.com.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.