The pharmacokinetics and clinical tolerability of ascending single doses of BNC210, an anxiolytic compound, in healthy volunteers

Phase 1

Completed

• Conditions: Generalised Anxiety Disorder; Mental Health - Anxiety

• Registration Number: ACTRN12609000577213
• Lead Sponsor: Bionomics Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

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

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).
11.Clinically significant abnormal electrocardiogram (ECG) (12-lead) at the screening visit or prior to dosing on Day 1, as determined by the Investigator.
12.Subjects who have a marked prolongation of the QT corrected (QTc) interval (i.e., repeated demonstration of a QTc interval >450 msec for females or >430 msec for males) at screening or prior to dosing on Day 1 will not be allowed to continue in the study.
13.Significant history of illicit drug or alcohol use or abuse (as determined by the Investigator) within 1 year of the Screening Visit.
14.Any alcohol use within 24 hours prior to dosing on Day 1.
15.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 subject's returning for follow-up visits on schedule.
16.Blood donation (1 unit or more) within 1 month prior to the screening visit.
17.Smoke >5 cigarettes per day.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the pharmacokinetics of single doses of BNC210. Plasma and urine samples will be collected for pharmacokinetic assessment. The samples will be assayed by a validated Liquid Chromatography/Mass Spectrometry (LC/MS) method which is specific for the determination of BNC210[from baseline to 32 hours post dose];To determine the clinical tolerability of single doses of BNC210. This will be assessed using scheduled adverse event probes, spontaneous adverse event reporting, physical examination, routine laboratory investigations, Electrocardiogram (ECG) and vital sign evaluations plus clinical chemistry analysis (haematology, biochemistry, urinalysis)[from baseline to 8 days (+/- 3 days ) post dosing]

Secondary Outcome Measures

Name	Time	Method
To determine the effects of BNC210 on neurological and psychiatric symptoms using Bond and Lader visual analogue scales.[from baseline to 32 hours post dose];To identify a dose range to be used in subsequent trials.[from baseline to 8 days (+/- 3 days ) post dosing]