A Single dose safety and tolerability study of oral noribogaine in healthy volunteers

Phase 1

Completed

• Conditions: Safety and tolerability study of oral noribogaine in Healthy Volunteer Participants; Other - Research that is not of generic health relevance and not applicable to specific health categories listed above

• Registration Number: ACTRN12612000821897
• Lead Sponsor: DemeRx, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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[These will be assessed frequently over 72 hours then periodically duing the next 6 days following a single dose.];To determine the tolerability of noribogaine in a healthy normal participant population. This will be assessed by clinical observation and adverse event reporting. <br><br>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.[These will be assessed frequently over 72 hours then periodically during the next 6 days following a single dose]

Secondary Outcome Measures

Name	Time	Method
To determine the pharmacokinetic profile of noribogaine in the study participants. This will be assessed using blood samples that will be analyzed for noribogaine.[Samples will be obtained frequently over 72 hours, then periodically over the next 6 days following a single dose.];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[This will be assessed frequently over 72 hours then periodically over the next 6 days following a single dose.]