None listed
Conditions
Brief summary
This is a phase 1a, single-centre, randomized, open label study to evaluate the safety, tolerability and pharmacokinetics of a single sublingual or oral dose of GDN-1 in adult healthy volunteers. There are 6 treatment arms.
Interventions
A single dose of GDN-1 will be administered on Day 0 either sublingually or orally in either a fed or fasted state according to the randomisation schedule. Patients will be randomised into one of six treatment groups:
Group 1, 10mg of sublingual GDN-1 in a fasted state,
Group 2, 20mg of sublingual GDN-1 in a fasted state,
Group 3, 40mg of sublingual GDN-1 in a fasted state,
Group 4, 40mg of sublingual GDN-1 in a fed state,
Group 5, 40mg of oral GDN-1 in a fasted state,
Group 6, 40mg of oral GDN
A single dose of GDN-1 will be administered on Day 0 either sublingually or orally in either a fed or fasted state according to the randomisation schedule. Patients will be randomised into one of six treatment groups: Group 1, 10mg of sublingual GDN-1 in a fasted state, Group 2, 20mg of sublingual GDN-1 in a fasted state, Group 3, 40mg of sublingual GDN-1 in a fasted state, Group 4, 40mg of sublingual GDN-1 in a fed state, Group 5, 40mg of oral GDN-1 in a fasted state, Group 6, 40mg of oral GDN-1 in a fed state,
Sponsors
Gordagen Pharmaceuticals Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects who: 1. Are adults aged between 18 and 55 years inclusive at the time of consent. 2. Have a Body Mass Index (BMI) of greater than or equal to 18.5 and less than or equal to 27kg/m2 3. Have voluntarily given written informed consent.
Exclusion criteria
Subjects who: 1. Are female and breastfeeding and/or of reproductive potential with a positive urine beta human chorionic gonadotropin (beta-HCG) pregnancy test at either Screening or the Baseline Visit; 2. Are of child bearing potential and are not able or willing to comply with contraceptive requirements for study participation; 3. Are taking regular prescription or OTC medications, other than contraception medications within 30 days of the Baseline Visit and are unwilling to abstain from taking these for the duration of the study; 4. Received blood or plasma derivatives in the 3 months preceding the first study dosing 5. Donated blood in the three months preceding the first study dosing or intend to make blood donation during the study, or within the three months following the study completion 6. Volunteers that are unable to comply with the study procedures/schedule including but not limited to being able to fast or consume the standard meals that will be provided. 7. Are taking Vitamin E or Vitamin E containing preparations within the last 3 months prior to the Baseline Visit and are unwilling to abstain from taking these for the duration of the study; 8. Have a history of or current clinically significant gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, oncological, immunodeficiency, neurological, metabolic, haematological or autoimmune disorder or other clinically significant medical conditions that in the investigator’s opinion, may increase the risk of participation; 9. Have an existing impairment to their alimentary tract (including oral cavity) which may interfere with investigational product administration and absorption; 10. Have an impaired sense of taste (self reported); 11. Have an active infection; 12. Have a history of chronic alcohol or drug abuse in the three-months period prior to Screening; 13. Are current smokers, or have a history of smoking within the three months prior to Screening; 14. Have a history of adverse reactions to any of the study medications or components; 15. Have taken aspirin or other medication which may increase the risk of bleeding within the 2 weeks prior to Baseline; 16. Are known to be HIV, hepatitis B or C positive (note, these will not be tested for); 17. Have laboratory blood values: a. Haemoglobin <120 grams/litre (g/L) for men and <11.0 g/L for women b. Neutrophil count <1 x 109/L c. Platelet count < 80 x 109/L d. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the upper limit of normal (ULN) e. Amylase >1.5 times ULN (unless serum lipase is less than or equal to 1.5 times ULN) f. Subjects with an estimated creatinine clearance of <80 mL/minute (min) g. INR > ULN 18. Have received any investigational drug within 30 days prior to the Baseline visit
Outcome results
None listed