A single dose, cross-over pharmacokinetic study comparing oral formulations of BNC210 in healthy male volunteers

Completed

• Conditions: Anxiety; Trauma and stressor related disorders; Mental Health - Anxiety; Mental Health - Other mental health disorders

• Registration Number: ACTRN12618001197224
• Lead Sponsor: Bionomics Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-18
• Study Completion: 2018-10-31
• Last Update Posted: 10 December 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 6

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the pharmacokinetic profile of suspension (fasted) and tablet (fasted and fed) oral formulations of BNC210.[PK blood samples will be taken at the following time points for each treatment arm: Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3, 4, 6, 8, 12, 18 and 24 hours post-dose.]

Secondary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of suspension and tablet oral formulations of BNC210.[Scheduled adverse event (AE) probes will occur at the following time points for each treatment arm: 1, 2, 4, 6, 8, 12 and 24 hours post-dose. Spontaneous AE reporting will also occur throughout the study.<br>Physical examinations will occur at screening, and for each treatment arm on the day before dosing and 24 hours post-dose.<br>Routine laboratory tests will be performed at screening, on the day before dosing for each treatment arm, and 24 hours post-dose for the last treatment arm.<br>Vital sign evaluations will be performed at screening, and at the following time points for each treatment arm: Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose.<br>]