ACTRN12609000577213
Completed
Phase 1
The pharmacokinetics and clinical tolerability of ascending single doses of BNC210, an anxiolytic compound, in healthy volunteers
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bionomics Limited
- Enrollment
- 4
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Good general health without clinically significant renal, hepatic, cardiac or respiratory disease, as determined by the principal investigator.
- •2\.Good general mental health as determined by scores on the Symptom Checklist\-90\-R (SCL\-90\-R (registered trademark)), a screening instrument which evaluates a broad range of psychological problems and symptoms of psychopathology.
- •3\.Agree to and be capable of signing informed consent form.
- •4\.Have suitable venous access for blood sampling.
- •5\.Body Mass Index within the range of 19\-30 kg/m2\.
Exclusion Criteria
- •1\.Renal impairment as evidenced by estimated creatinine clearance, measured by the Cockcroft\-Gault method of less than 90 mL/min.
- •2\.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.
- •3\.A score of more than two standard deviations from the mean on any of the key nine scales in the SCL\-90\-R (registered trademark)
- •4\.Any medical condition that in the opinion of the investigator may adversely impact on the participant’s ability to complete the study.
- •5\.Plasma Aspartate transaminase (AST), Alanine transaminase (ALT), and Alkaline phosphatase (ALP) tests in excess of 1\.5 times the upper limit of normal.
- •6\.History of severe allergic or anaphylactic drug\-related reactions.
- •7\.Current (within the last six months) clinically significant psychiatric disorder including anxiety or depression.
- •8\.Concurrent use of other medication on a regular or daily basis.
- •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 or human immunodeficiency virus (HIV).
Outcomes
Primary Outcomes
Not specified
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