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

Phase 1

Completed

• Conditions: Generalised Anxiety Disorder; Mental Health - Anxiety

• Registration Number: ACTRN12610000442000
• Lead Sponsor: Bionomics Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 4

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

Exclusion Criteria

1. Renal impairment - creatine clearance less than 90 mL/min (Cockcroft-Gault method)
2. Laboratory value at screening outside the normal range, unless it is judged by investigator as not clinically significant after appropriate evaluation
3. Score of more than 2 standard deviations from the mean on any of the key 9 scales in the Symptom Checklist -90 - Revised (SCL-90-R)
4. Any medical condition that in the opinion of the investigator may adversely impact on ability to complete the study
5. Plasma Aspartate transaminase (AST), alanine transaminase (ALT), Alkaline phosphatase (ALP) tests in excess of 1.5 times the upper limit of normal
6. Laboratory evidence of clinically significant serum iron deficiency
7. History of severe allergic or anaphylactic drug-related reactions
8. Current (within last 6 months) clinically significant psychiatric disorder including anxiety or depression
9. Concurrent use of medication ona regular or daily basis
10. Participation in another clinical trial of an investigational agent within 30 days of study entry
11. Known history of past or present infection with hepatitis C virus, hepatitis B or human immuno-deficiency virus (HIV)
12. Clinically significant abnormal electrocardiogram (ECG) (12 lead) at screening visit or prior to dosing on Day 1 as determined by the investigator
13. Marked prolongation of the QTcB interval (ie repeated demonstration of QTcB interval >430 for males)at screening or prior to dosing on Day 1
14. Significant history of illicit drug or alcohol use or abuse within 1 year of screening
15. Any alcohol use with 24 hrs prior to dosing on Day 1
16. Unwillingness or inability to comply with requirements of the protocol
17. Blood donation (1 unit or more) within 1 month prior to screening
18. Smoke >5 cigarettes per day
19. Previous enrolment in study BNC210.001

Study & Design

• Study Type: Interventional
• Study Design: Not specified