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Trial registered on ANZCTR


Registration number
ACTRN12616001712493
Ethics application status
Approved
Date submitted
8/12/2016
Date registered
14/12/2016
Date last updated
7/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study of Viagra and XCalibur in Healthy Volunteers.
Scientific title
A Two-Way, Single-Dose, Fasting, Bioequivalence Study of XCalibur Trademark 50mg Capsules versus Viagra Registered Trademark 50mg Film-Coated Tablets in Healthy Male Volunteers
Secondary ID [1] 290676 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Erectile dysfunction 301207 0
Condition category
Condition code
Renal and Urogenital 300969 300969 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will take part in two inpatient periods, with a minimum of a 4-day washout between periods. Participants will receive a single 50mg dose of oral XCalibur (sildenafil) capsule during one inpatient period and a single oral dose of Viagra film-coated tablet during another inpatient period. No food is allowed for 10 hours before taking study medication and for 4 hours after the dose. Water and other non-caffeinated beverages are allowed except for 1 hour before and after study medication. Participants will be admitted to the clinical research unit the evening before each in­patient period and will remain in the clinic until 14 hours post dose.
Intervention code [1] 296563 0
Treatment: Drugs
Comparator / control treatment
Participants will receive a single oral dose of Viagra 50 mg tablet.
Control group
Active

Outcomes
Primary outcome [1] 300397 0
Comparison of XCalibur to Viagra using standard bioequivalence criteria. The method of evaluation for the Primary Objective will be standard bioequivalence criteria (90% CIs) of test product versus reference product for Area under the plasma concentration-time curve from time zero to infinity and observed maximum plasma concentration. The pharmacokinetic analysis will be based on plasma concentrations of sildenafil
Timepoint [1] 300397 0
Blood samples for pharmacokinetic analysis will be collected pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hours post-dose
Secondary outcome [1] 329883 0
Comparison of the safety and tolerability of XCalibur Trademark capsule and Viagra Registered Trademark film-­-coated tablet through assessment of adverse events. The most common expected adverse events associated with sildenafil (the active ingredient in the study medication) include hypotension (low blood pressure), flushing and headache. Adverse events will be collected through adverse event probes and collection of vital signs.
Timepoint [1] 329883 0
Collection of adverse events will begin at time of initial dose of study medication through the follow-up visit (5 days after the last dose of study medication). Vital signs will be monitored pre-dose, at 30 minutes, and at hours 1, 2, 4, 6, 8, and 14 after taking study medication. Adverse event probes will be completed at the same time as post-dose vital signs.

Eligibility
Key inclusion criteria
1. In good general health without clinically significant disease, as determined by the Principal Investigator.
2. Have suitable venous access for blood sampling.
3. Body mass index (BMI) of 19.0 – 30.0 kg/square meters (inclusive).
4. Deemed able to read and understand English in order to communicate with research staff and complete protocol required questionnaires and forms.
5. Has not smoked cigarettes within 6 months of the screening visit.
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Past history of hypersensitivity to sildenafil or any of its excipients, or severe allergic or anaphylactic reaction to any other drug.
2. A medical condition that, in the opinion of the Investigator, may adversely impact the participant’s ability to complete the study (e.g. priapism, easy fainting, abnormal blood pressure, heart disease, retinitis pigmentosa or optic neuropathy or other risk factors of non-arteritic anterior ischaemic optic neuropathy (NAION), or anaemia).
3. Intake of any prescribed drugs within 2 weeks or Over-The-Counter (OTC)/non-prescribed drugs, vitamins/supplements, or herbal medicines within 1 week of study medication.
4. Use of drugs with enzyme-inducing properties (such as rifampicin and St John’s Wort) within 3 weeks or 5 half-lives, whichever is greater, prior to treatment period 1 and throughout the study, or any drug known to be a strong inhibitor of CYP3A4 within 5 half-lives of treatment period 1 and throughout the study.
5. Known or suspected drug or alcohol abuse or dependence.
6. Positive results on the urine drug screen or breath alcohol test.
7. Positive for hepatitis C virus (HCV), hepatitis B or human immunodeficiency virus (HIV).
8. Has received another investigational agent or new chemical entity (defined as a compound which has not been approved for marketing) within 30 days prior to the Screening visit.

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/12/2016
Date of last participant enrolment
Anticipated
Actual
22/01/2017
Date of last data collection
Anticipated
31/01/2017
Actual
2/02/2017
Sample size
Target
48
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 295106 0
Commercial sector/Industry
Name [1] 295106 0
iX Biopharma Ltd.
Country [1] 295106 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
iX Biopharma Ltd.
Address
24 Augusta Street, Willetton, WA 6155, Australia
Country
Australia
Secondary sponsor category [1] 293926 0
None
Name [1] 293926 0
None
Address [1] 293926 0
None
Country [1] 293926 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296467 0
Bellberry Limited
Ethics committee address [1] 296467 0
129 Glen Osmond Rd.
Eastwood SA 5063
Ethics committee country [1] 296467 0
Australia
Date submitted for ethics approval [1] 296467 0
Approval date [1] 296467 0
28/11/2016
Ethics approval number [1] 296467 0
2016-11-801

Summary
Brief summary
iX Biopharma Pty Ltd is developing a new capsule formulation of sildenafil for treating erectile dysfunction. Sildenafil as a drug has been approved by the Therapeutic Goods Administration (TGA) in Australia, but the capsule formulation of sildenfil has not been approved by the TGA Therapeutic Goods Administration in Australia or in any other country. This particular formulation of sildenafil, XCalibur (the study drug), and its use in this study are experimental. The study drug will be compared to the pre-existing tablet formulation Viagra.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70926 0
Dr Sam Salman
Address 70926 0
Linear Clinical Research Ltd
1st Floor, B Block, QEII Medical Centre
Hospital Avenue,
Nedlands WA 6009
Country 70926 0
Australia
Phone 70926 0
+61 8 6382 5100
Fax 70926 0
Email 70926 0
[email protected]
Contact person for public queries
Name 70927 0
Simon Scott
Address 70927 0
Linear Clinical Research Ltd
1st Floor, B Block, QEII Medical Centre
Hospital Avenue,
Nedlands WA 6009
Country 70927 0
Australia
Phone 70927 0
+61 8 6382 5100
Fax 70927 0
Email 70927 0
[email protected]
Contact person for scientific queries
Name 70928 0
Sam Salman
Address 70928 0
Linear Clinical Research Ltd
1st Floor, B Block, QEII Medical Centre
Hospital Avenue,
Nedlands WA 6009
Country 70928 0
Australia
Phone 70928 0
+61 8 6382 5100
Fax 70928 0
Email 70928 0
[email protected]

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

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