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Trial registered on ANZCTR


Registration number
ACTRN12612000821897
Ethics application status
Approved
Date submitted
31/07/2012
Date registered
6/08/2012
Date last updated
8/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A Single dose safety and tolerability study of oral noribogaine in healthy volunteers
Scientific title
A single centre, double blind, randomised, placebo controlled, parallel group, ascending single dose, safety and tolerability, pharmacokinetic and pharmacodynamic study of oral noribogaine in healthy participants
Secondary ID [1] 280938 0
Nil
Universal Trial Number (UTN)
U1111-1133-0446
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Safety and tolerability study of oral noribogaine in Healthy Volunteer Participants 287033 0
Condition category
Condition code
Other 287360 287360 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
Planned Doses as follows:
Dose Level 1 (1st cohort) : single capsule containing 3 mg noribogaine or methylcellulose placebo
Dose Level 2 (2nd cohort):single capsule containing 10 mg noribogaine or methylcellulose placebo
Dose Level 3 (3rd cohort): single capsule containing 30 mg noribogaine or methylcellulose placebo
Dose Level 4 (4th cohort): single capsule containing 60 mg noribogaine or methylcellulose placebo
Intervention code [1] 285373 0
Treatment: Drugs
Comparator / control treatment
Identical capsule containing methylcellulose as Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 287633 0
To determine the safety of noribogaine in a healthy normal participant population. This will be assessed by observations including physical examinations, clinical laboratory tests and ECGs
Timepoint [1] 287633 0
These will be assessed frequently over 72 hours then periodically duing the next 6 days following a single dose.
Primary outcome [2] 287634 0
To determine the tolerability of noribogaine in a healthy normal participant population. This will be assessed by clinical observation and adverse event reporting.

Expected adverse events are not known with certainty but may include events commonly seen with serotonergic medications such as certain antidepressants and opioids. Adverse events include participant reports and clinically significant abnormalities of observations defined in the protocol. All adverse events will be assessed by the principal investigator.
Timepoint [2] 287634 0
These will be assessed frequently over 72 hours then periodically during the next 6 days following a single dose
Secondary outcome [1] 298561 0
To determine the pharmacokinetic profile of noribogaine in the study participants. This will be assessed using blood samples that will be analyzed for noribogaine.
Timepoint [1] 298561 0
Samples will be obtained frequently over 72 hours, then periodically over the next 6 days following a single dose.
Secondary outcome [2] 298562 0
To determine the pharmacodynamic profile of noribogaine in the study participants. This will be measured by physiological assessments of analgesic and mu opioid agonist activity
Timepoint [2] 298562 0
This will be assessed frequently over 72 hours then periodically over the next 6 days following a single dose.

Eligibility
Key inclusion criteria
a) Provide written informed consent
b) Male or surgically sterilized female.
c) Body Mass Index greater than or equal to 18.5 and less than 30kg/m2 on the day of consent.
d) Healthy individuals as determined by medical history, physical examination, ECG, vital signs and laboratory tests.
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
a) Evidence from medical history, physical or laboratory examinations of significant neurologic, psychiatric, cardiac, respiratory, renal, hepatic, endocrine, gastrointestinal, immunological condition or any other diagnosed conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug, interfere with the ability to accurately record study measurements (e.g., cataracts) or which may potentiate or predispose to undesired effects.
b) Any history of seizure or convulsion, including febrile convulsion in childhood.
c) A history of alcohol or drug abuse or dependency
d) History of mental illness requiring medication or treatment by a physician.
e) Any participant for whom the investigator believes, for any reason, inclusion would not be an acceptable risk.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After obtaining consent and confirming eligibility, the participant will be randomised in the study. Study drug will be prepared for each participant by pharmacy staff, according to the randomisation code. All clinical staff will remain blinded. Individual randomisation envelopes will be provided in case the identity of study drug administered to a participant needs to be known.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety
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] 4451 0
New Zealand
State/province [1] 4451 0

Funding & Sponsors
Funding source category [1] 285723 0
Commercial sector/Industry
Name [1] 285723 0
DemeRx, Inc.
Address [1] 285723 0
4400 Biscayne Blvd., Suite 580
Miami, FL 33137
Country [1] 285723 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
DemeRx, Inc.
Address
4400 Biscayne Blvd., Suite 580
Miami, FL 33137
Country
United States of America
Secondary sponsor category [1] 284552 0
Commercial sector/Industry
Name [1] 284552 0
Zenith Technology Corporation Ltd
Address [1] 284552 0
156 Frederick Street
Dunedin 9016 Otago
Country [1] 284552 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287733 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 287733 0
Health and Disability Ethics Committees
1 the Terrace
PO Box 5013
Wellington, 6011
Ethics committee country [1] 287733 0
New Zealand
Date submitted for ethics approval [1] 287733 0
Approval date [1] 287733 0
30/07/2012
Ethics approval number [1] 287733 0
LRS/12/06/015

Summary
Brief summary
This study will investigate the safety and tolerability of noribogaine given to healthy people. It will examine how the drug is absorbed and excreted from the body. The study will also examine what effects noribogaine has on specific functions of the body.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34508 0
Address 34508 0
Country 34508 0
Phone 34508 0
Fax 34508 0
Email 34508 0
Contact person for public queries
Name 17755 0
Linda Folland
Address 17755 0
Zenith Technology Corporation Ltd
156 Frederick Street
Dunedin 9016, Otago
Country 17755 0
New Zealand
Phone 17755 0
+6434779669
Fax 17755 0
Email 17755 0
linda.folland@zenithtechnology.co.nz
Contact person for scientific queries
Name 8683 0
Professor Paul Glue
Address 8683 0
Dunedin School of Medicine
PO Box 913, Dunedin 9054, Otago
Country 8683 0
New Zealand
Phone 8683 0
+64 3 470 3867
Fax 8683 0
Email 8683 0
paul.glue@otago.ac.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