Determination of the Blood Pharmacodynamic Effects following a Single Dose of Oral Anatabine Citrate in Normal Healthy Volunteers
Phase 1
Completed
- Conditions
- Pharmacodynamic effects study conducted in healthy volunteers with no health condition or problem studied.This study is being conducted in healthy volunteers who are not being treated for the conditions that anatabine citrate are indicated for. Anatabine citrate is a naturally occurring alkaloid found in the Solanaceae plant family. It is also the ingredient of a number of dietary supplements.Pharmacodynamic effects study conducted in healthy volunteers with no health condition or problem studied.This study is being conducted in healthy volunteers who are not being treated for the conditions that anatabine citrate are indicated for. Anatabine citrate is a naturally occurring alkaloid found in the Solanaceae plant family. It is also the ingredient of a number of dietary supplements.Other - Research that is not of generic health relevance and not applicable to specific health categories listed above
- Registration Number
- ACTRN12615000098538
- Lead Sponsor
- Zenith Technology Corp Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Males or females
In good general health
Aged between 18-65 years of age inclusive
Weighing between 45 and 100 kg
Laboratory tests within normal ranges or assessed not significant by the Clinical Investigator
Normal ECG
Exclusion Criteria
Current users of tobacco (cigarettes or smokeless)
Current user of anatabine citrate dietary supplements
Allergy to any of the product ingredients
Significant medical condition that could in the Investigator's opinion interfere with the study, or put the subject at significant risk
Participation in any drug or medical device study within 30 days of entering this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the pharmacodynamic effects of a single oral dose of anatabine citrate on the ex vivo expression/activity of pro-inflammatory mediators from activated peripheral blood mononuclear cells in healthy adult volunteers.<br><br>At Visit 2, blood samples will be drawn prior to study product administration and one hour (+/- 10 minutes) post-dosing for evaluation of PD measures. Blood samples may also be evaluated for anatabine levels, although formal pharmacokinetic evaluations will not be performed. PD assessments will include evaluation of the production of pro-inflammatory mediators from PBMCs stimulated ex vivo with LPS. Relationships between PD outcomes and anatabine will be explored. Serum concentrations of anatabine will be determined by validated LC/MS/MS analytical methods.[Time zero and one hour after dosing.]
- Secondary Outcome Measures
Name Time Method ot applicable for this study[Not applicable for this study]