None listed
Conditions
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.
Interventions
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 medicat
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.
Sponsors
iX Biopharma Ltd.
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
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.
Outcome results
None listed