The effect of food on the pharmacokinetcs, tolerability and pharmacodynamics of BNC210 in healthy male volunteers
Bionomics Limited
4 participants
May 5, 2010
Interventional
Conditions
Eligibility
Inclusion Criteria6
- Adult males 18-65 years
- Good general health without significant renal, hepatic, cardiac or respiratory disease
- Good general mental health as determined by scores on the Symptom Checklist 90-R
- Agree to and be able to sign informed consent form
- Have suitable venous access for blood sampling
- Body mass index (BMI) within 19-30 kg/m2
Exclusion Criteria19
- Renal impairment - creatine clearance less than 90 mL/min (Cockcroft-Gault method)
- Laboratory value at screening outside the normal range, unless it is judged by investigator as not clinically significant after appropriate evaluation
- Score of more than 2 standard deviations from the mean on any of the key 9 scales in the Symptom Checklist -90 - Revised (SCL-90-R)
- Any medical condition that in the opinion of the investigator may adversely impact on ability to complete the study
- Plasma Aspartate transaminase (AST), alanine transaminase (ALT), Alkaline phosphatase (ALP) tests in excess of 1.5 times the upper limit of normal
- Laboratory evidence of clinically significant serum iron deficiency
- History of severe allergic or anaphylactic drug-related reactions
- Current (within last 6 months) clinically significant psychiatric disorder including anxiety or depression
- Concurrent use of medication ona regular or daily basis
- Participation in another clinical trial of an investigational agent within 30 days of study entry
- Known history of past or present infection with hepatitis C virus, hepatitis B or human immuno-deficiency virus (HIV)
- Clinically significant abnormal electrocardiogram (ECG) (12 lead) at screening visit or prior to dosing on Day 1 as determined by the investigator
- Marked prolongation of the QTcB interval (ie repeated demonstration of QTcB interval >430 for males)at screening or prior to dosing on Day 1
- Significant history of illicit drug or alcohol use or abuse within 1 year of screening
- Any alcohol use with 24 hrs prior to dosing on Day 1
- Unwillingness or inability to comply with requirements of the protocol
- Blood donation (1 unit or more) within 1 month prior to screening
- Smoke >5 cigarettes per day
- Previous enrolment in study BNC210.001
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Interventions
Participants will receive up to four dose of BNC210 - 300, 600, 1200,and 2000 mg. Doses of 300, 600 and 1200mg of BNC210 will be administered as an oral suspension in 10 mL of vehicle or 10 mL vehicle alone (placebo). Participants in the 2000 mg of BNC210 dosing group (Period 5) will be given an oral suspension in 20 mL of vehicle or 20 mL of vehicle alone (placebo). The starting dose in this study is 300 mg of BNC210 or placebo without food. The following week, the same 4 participants will receive 300 mg of BNC210 or placebo with food. If there is a >50% increase in drug exposure with food, then the participants' will be dose escalated - with a one week washout period between each dose. Escalation to the next dose will be decided in a safety review meeting held before the next dosing period.
Locations(1)
View Full Details on ANZCTR
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ACTRN12610000442000