None listed
Conditions
Brief summary
This trial will involve 6 healthy male volunteers to determine the pharmacokinetics and safety/tolerability of the investigational drug NV-27.
Interventions
6 healthy male volunteers will each take 400mg of study drug NV-27 once, orally on day 1. The participants will be closely monitored for 5 days to determine the pharmacokinetics and tolerability of NV-27. Participants will then be required to return 4 weeks after taking NV-27 to assess their tolerability and the safety of NV-27.
Sponsors
Novogen Research Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
a) Normal healthy male volunteers b) At screening, patients must have all clinical pathology analytes within the laboratory’s reference ranges c) Participants must be 18 - 40 years of age d) Non-smokers e) Participants must be able to understand the risks and benefits of the study and give written informed consent to participation
Exclusion criteria
a) Participants who are on a concurrent investigational drug study or who have had any treatment with any investigational agents within 4 weeks of commencing the study b) Alcohol consumption of > 40g per day c) A history of alcohol or drug dependence within the last three years d) A chronic illness which requires regular therapy e) Asthma f) Previous hypersensitivity or allergy to aspirin or other anti-inflammatory agents g) Use of any prescription medication within the preceding week
Outcome results
None listed