None listed
Conditions
Brief summary
The study is being conducted as the second study (Phase 1) in the clinical development of NV-52 as a new drug for inflammatory bowel disease. It is important to know that patients who are entered onto Phase I studies generally start with one dose of the drug(s) to be tested, then take doses of the drug over the following days. The purpose of the study is to determine the “bio-availability”, that is, can the drug be detected in blood or urine of NV-52 when administered orally (pill form). Also, to see if the drug is well tolerated in patients, without side effects.
Interventions
NV-52 is an experimental drug which is being developed as an orally-delivered non-toxic agent being developed for the maintenance of remission in inflammatory bowel disease (IBD). The duration of intervention is 10 days at a dose of 400 mg per day with no control group.
Sponsors
Novogen Research Pty Limited
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
Adult patients will be enrolled who • are non-smokers• are on no regular medication (except the oral contraceptive pill - OCP)• have no chronic disease which requires regular therapy• a daily alcohol intake of < 40g• have no history of alcohol or other drug dependence.
Exclusion criteria
Patients who are on a concurrent investigational drug study or who have had any treatment with any investigational agents within 4 weeks of commencing the studyAlcohol consumption of > 40g per dayA history of alcohol or drug dependence within the last three yearsA chronic illness which requires regular therapyAsthmaPrevious hypersensitivity or allergy to aspirin or other anti-inflammatory agents Use of any prescription medication within the preceding week other than the oral contraceptive pillFemales not using adequate contraception.
Outcome results
None listed