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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000821897

Enrollment

Registered

2012-08-06

Start date

2012-08-06

Completion date

2012-11-07

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Outcome results