The effect of food on the pharmacokinetcs, tolerability and pharmacodynamics of BNC210 in healthy male volunteers

INTERVENTION: Participants will receive up to four dose of BNC210 ‐ 300, 600, 1200,and 2000 mg. Doses of 300, 600 and 1200mg of BNC210 will be administered as an oral suspension in 10 mL of vehicle or 10 mL vehicle alone (placebo). Participants in the 2000 mg of BNC210 dosing group (Period 5) will be given an oral suspension in 20 mL of vehicle or 20 mL of vehicle alone (placebo). The starting dose in this study is 300 mg of BNC210 or placebo without food. The following week, the same 4 participants will receive 300 mg of BNC210 or placebo with food. If there is a >50% increase in drug exposure with food, then the participants' will be dose escalated ‐ with a one week washout period between each dose. Escalation to the next dose will be decided in a safety review meeting held before the next dosing period. CONDITION: Generalised Anxiety Disorder PRIMARY OUTCOME: To determine the effect of food on the pharmacokinetics of BNC210 by measuring levels of BNC210 in plasma samples collected during the study. To determine the general clinical tolerability of BNC210 by assessing vital signs, electrocardiogram (ECG) readings, and performing routine haematology and clinical chemistry assessments on blood and urine samples collected during the study. SECONDARY OUTCOME: To measure the serum cortisol levels in order to evaluate it as a potential marker of central nervous system effects of BNC210 INCLUSION CRITERIA: 1. Adult males 18‐65 years 2. Good general health without significant renal, hepatic, cardiac or respiratory disease 3. Good general mental health as determined by scores on the Symptom Checklist 90‐R 4. Agree to and be able to sign informed consent form 5. Have suitable venous access for blood sampling 6. Body mass index (BMI) within 19‐30 kg/m2