CompletedPhase 1ACTRN12607000611426

Phase Ia Pharmacokinetic and Tolerability Study of Oral NV-27 in Normal Healthy Volunteers

Sponsor

Novogen Research Pty Ltd

Enrollment

6 participants

Start Date

Dec 10, 2007

Study Type

Interventional

Conditions

Safety and tolerability of the investigational drug NV-27 in healthy male volunteers

Summary

This trial will involve 6 healthy male volunteers to determine the pharmacokinetics and safety/tolerability of the investigational drug NV-27.

Eligibility

Sex: MalesMin Age: 18 YearssMax Age: 40 Yearss

Inclusion Criteria5

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 Criteria7

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

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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.

Locations(1)

Australia

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ACTRN12607000611426