ACTRN12619001180101CompletedPhase 1
The pharmacokinetics and clinical tolerability of ascending single doses of an oral tablet formulation of BNC210 in healthy male volunteers
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Bionomics Limited
- Enrollment
- 5
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to 65 Years (—)
- Sex
- Male
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/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.
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 >440 msec 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/e-cigarettes, tobacco and/or tetrahydrocannabinol containing products within 2 weeks prior to first dose.
Investigators
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