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Trial registered on ANZCTR


Registration number
ACTRN12615000098538
Ethics application status
Approved
Date submitted
23/12/2014
Date registered
4/02/2015
Date last updated
21/10/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Determination of the Blood Pharmacodynamic Effects following a Single Dose of Oral Anatabine Citrate in Normal Healthy Volunteers
Scientific title
A single site, open label study to evaluate the pharmacodynamic effects of a single dose of oral anatabine citrate in healthy adult volunteers.
Secondary ID [1] 285891 0
None
Universal Trial Number (UTN)
U1111-1163-5079
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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.
293814 0
Condition category
Condition code
Other 294115 294115 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose study where each participant receives one dose of anatabine citrate on one occasion. The dosage will be either 3 or 4 mg oral tablet based on body weight taken with 240 ml water. If the subject weighs less than or equal to 81.4 kg the dose given will be 3 mg. If the subject weighs 81.5 kg or above they will receive 4 mg. The intervention for this trial is the test formulation of anatabine citrate.

All subjects will receive their dosage and blood samples will be collected immediately prior to dosing and then one hour after dosing via venipuncture.

Subjects who meet the inclusion and exclusion criteria will be included in this study. Pre and post study laboratory tests will be performed along with an ECG and medical evaluation. A follow up visit will also be completed to assess for safety.
Intervention code [1] 290873 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293913 0
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.

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.
Timepoint [1] 293913 0
Time zero and one hour after dosing.
Secondary outcome [1] 312142 0
Not applicable for this study
Timepoint [1] 312142 0
Not applicable for this study

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is an open label, nonrandomised, uncontrolled study with one treatment.

Each participant will be identified by a 3 digit screening number and a 2 digit subject number. The screening number will be issued once the participant has given written consent to participate in the study and the two digit subject number will be issued after acceptance into the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects will be accepted onto the study based on the order of enrollment. No randomisation programme will be used.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6568 0
New Zealand
State/province [1] 6568 0
Otago

Funding & Sponsors
Funding source category [1] 290474 0
Commercial sector/Industry
Name [1] 290474 0
Rock Creek Pharmaceuticals, Inc
Address [1] 290474 0
2040 Whitfield Ave, Suite 300
Sarasota, FL 34243
Country [1] 290474 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corp Ltd
Address
156 Frederick Street
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 289176 0
None
Name [1] 289176 0
Address [1] 289176 0
Country [1] 289176 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292143 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 292143 0
Ministry of Health
Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 292143 0
New Zealand
Date submitted for ethics approval [1] 292143 0
30/10/2014
Approval date [1] 292143 0
22/12/2014
Ethics approval number [1] 292143 0
14/NTA/193

Summary
Brief summary
To evaluate the pharmacodynamic effects of a single dose of oral anatabine citrate in healthy volunteers.
Trial website
Trial related presentations / publications
No presentations or citations available. Final CSR provided to Sponsor Company for Registration Purposes
Public notes

Contacts
Principal investigator
Name 53714 0
Dr Noelyn Hung
Address 53714 0
Zenith Technology Corporation Limited
156 Frederick Street
Dunedin 9016
Country 53714 0
New Zealand
Phone 53714 0
+6434779669
Fax 53714 0
+6434779605
Email 53714 0
noelyn.hung@otago.ac.nz
Contact person for public queries
Name 53715 0
Mrs Linda Folland
Address 53715 0
Zenith Technology Corporation Limited
156 Frederick Street
Dunedin 9016
Country 53715 0
New Zealand
Phone 53715 0
+6434779669
Fax 53715 0
+6434779605
Email 53715 0
linda.folland@zenithtechnology.co.nz
Contact person for scientific queries
Name 53716 0
Dr Cheung-Tak Hung
Address 53716 0
Zenith Technology Corporation Limited
156 Frederick Street
Dunedin 9016
Country 53716 0
New Zealand
Phone 53716 0
+6434779669
Fax 53716 0
+6434779605
Email 53716 0
tak.hung@zenithtechnology.co.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary