A Phase I, Randomised, Open Label Study of the Safety, Tolerability and Pharmacokinetics of Single Sublingual or Oral Dose of GDN-1 in Adult Healthy Volunteers.

Exclusion Criteria26

• Subjects who:
• 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;
• Are of child bearing potential and are not able or willing to comply with contraceptive requirements for study participation;
• 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;
• Received blood or plasma derivatives in the 3 months preceding the first study dosing
• 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
• 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.
• 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;
• 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;
• Have an existing impairment to their alimentary tract (including oral cavity) which may interfere with investigational product administration and absorption;
• Have an impaired sense of taste (self reported);
• Have an active infection;
• Have a history of chronic alcohol or drug abuse in the three-months period prior to Screening;
• Are current smokers, or have a history of smoking within the three months prior to Screening;
• Have a history of adverse reactions to any of the study medications or components;
• Have taken aspirin or other medication which may increase the risk of bleeding within the 2 weeks prior to Baseline;
• Are known to be HIV, hepatitis B or C positive (note, these will not be tested for);
• 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
• Have received any investigational drug within 30 days prior to the Baseline visit