The pharmacokinetics and clinical tolerability of ascending single doses of an oral tablet formulation of BNC210 in healthy male volunteers

Bionomics Limited0 sites5 target enrollmentAugust 20, 2019

Overview

No summary available.

Registry

who.int

Start Date

August 20, 2019

End Date

September 30, 2019

Last Updated

6 years ago

Study Type

Interventional

Sex

Male

Sponsor

•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/m2\.
•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. A highly effective method of birth control includes vasectomy
•or the use of a condom in combination with barrier methods, hormonal birth control or intrauterine device by the female partner.

•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).