Clinical TrialPlaceboCompleted

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

This randomised controlled parallel group Phase I trial (n=36) evaluated the safety and efficacy of noribogaine for safety and tolerability study of oral noribogaine in healthy volunteer participants.

Target Enrollment
36 participants
Study Type
Phase I interventional
Design
Randomized

Detailed Description

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.

Study Arms & Interventions

Experimental Arm

experimental

Interventions

  • Placebo

Participants

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 Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomized
  • Target Enrollment36 participants
  • Timeline
    Start: 2012-08-06
    End: 2012-11-07
  • Compound
    Placebo

Locations

Unknown facility — Australia

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