None listed
Conditions
Brief summary
Bionomics Limited is developing BNC210 for the treatment of anxiety, and trauma- and stressor-related, disorders including Post-Traumatic Stress Disorder (PTSD). This single-centre study, will evaluate the pharmacokinetic profile, as well as the safety and tolerability, of single ascending doses of BNC210 in five healthy male volunteers. Participants will receive single doses of 600 mg, 900 mg and 1200 mg BNC210 as a tablet formulation, during three separate dose periods. There will be a minimum 5 day washout period between each dose period.
Interventions
Every participant will receive each dose of BNC210 described below in three separate dose periods, with a 5-day washout period between each dose:
Dose period 1 - BNC210 600 mg, single dose, oral tablet
Dose period 2 - BNC210 900 mg, single dose, oral tablet
Dose period 3 - BNC210 1200 mg, single dose, oral tablet
Sponsors
Bionomics Limited
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Agree to and be capable of signing informed consent form. 2. Adult males aged 18-65 years (inclusive). 3. Body mass index within the range of 18-30 kg/m2. 4. Good general health without clinically significant renal, hepatic, cardiac or respiratory disease, as determined by the Investigator. 5. Have suitable venous access for blood sampling. 6. Agree to abstain from sexual intercourse or use a highly effective method of birth control with partners of childbearing potential for the duration of the study and for 3 months after the last dose of study drug. A highly effective method of birth control includes vasectomy or the use of a condom in combination with barrier methods, hormonal birth control or intrauterine device by the female partner.
Exclusion criteria
1. Any medical condition that in the opinion of the Investigator may adversely impact on the participant’s ability to complete the study. 2. Renal impairment as evidenced by estimated creatinine clearance, measured by the Cockcroft-Gault method of less than 90 mL/min. 3. Have a laboratory value at the Screening Visit that is outside the normal range, unless it is judged by the Investigator as not clinically significant after appropriate evaluation. 4. Plasma AST (aspartate transaminase), ALT (alanine transaminase), and ALP (alkaline phosphatase) tests in excess of 1.5 times the upper limit of normal. 5. History of severe allergic or anaphylactic drug-related reactions. 6. Known past or present mental health disorder. 7. Concurrent use of any prescription medication, over the counter medication or complementary / alternative medication within 2 weeks prior to dosing (single or multiple doses). 8. Consumption of grapefruit, grapefruit juice, red wine or St. John’s Wort within 2 weeks prior to first dose. 9. Participation in another clinical trial of an investigational agent within 30 days of study entry. 10. Known history of past or present infection with hepatitis C virus (HCV), hepatitis B (HBV) or human immunodeficiency virus (HIV). 11. Clinically significant abnormal ECG (12-lead) at the Screening Visit as determined by the Investigator. 12. Participants who have a marked prolongation of the QTcF corrected interval (i.e., repeated demonstration of a QTcF interval >440 msec at Screening. 13. Significant history of illicit drug or alcohol use or abuse (as determined by the Investigator) within 1 year of the Screening Visit. 14. Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the participant returning for visits on schedule. 15. Blood donation (1 unit or more) within 1 month prior to the Screening Visit. 16. Smoked cigarettes/e-cigarettes, tobacco and/or tetrahydrocannabinol containing products within 2 weeks prior to first dose.
Outcome results
None listed