None listed
Conditions
Brief summary
BNC210 is being developed for the treatment of anxiety, and trauma- and stressor-related, disorders including post-traumatic stress disorder (PTSD). This three-way crossover single dose study will compare the pharmacokinetic profiles of oral suspension and tablet formulations of BNC210.
Interventions
Arm 1 - BNC210 300mg oral suspension, fasted, single dose
Arm 2 - BNC210 2 x 150mg oral tablet, fasted, single dose
Arm 3- BNC210 2 x 150mg oral tablet, fed, single dose
The wash out period between each dose will be at least 5 days. Participants are randomly assigned to each Arm, but will all participate in each Arm once. Participants in Arm 1 and Arm 2 will fast for a minimum of 10 hours pre-dose, this fast will not include water except from 2 hours pre-dose. Participants in Arm 3 will fast for
Arm 1 - BNC210 300mg oral suspension, fasted, single dose Arm 2 - BNC210 2 x 150mg oral tablet, fasted, single dose Arm 3- BNC210 2 x 150mg oral tablet, fed, single dose The wash out period between each dose will be at least 5 days. Participants are randomly assigned to each Arm, but will all participate in each Arm once. Participants in Arm 1 and Arm 2 will fast for a minimum of 10 hours pre-dose, this fast will not include water except from 2 hours pre-dose. Participants in Arm 3 will fast for 9.5 hours and then consume a High Fat breakfast in its entirety within the 30 minutes prior to dosing. This fast will not include water except from 2 hours pre-dose. All investigational product will be monitored via accountability logs, and each dose will be administered and observed by study personnel.
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/m^2. 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.
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 >460 msec for females or >440 msec for males) 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, tobacco and/or tetrahydrocannabinol containing products within 2 weeks prior to first dose.
Outcome results
None listed