Clinical TrialSubstance Use Disorders (SUD)Completed

A Study to Assess 18-Methoxycoronaridine (18-MC HCl) in Healthy Volunteers

The primary objective of this Phase 1 double-blind, randomized, placebo-controlled study in healthy non-smoking volunteers is to assess safety and tolerability of single-day (SAD) and multiple-day (MAD) oral dosing of 18-MC HCl.

Target Enrollment
108 participants
Study Type
Phase I interventional
Design
Randomized, double Blind

Detailed Description

Phase 1, double-blind, randomized, placebo-controlled study in healthy non-smoking adults. Two parts: SAD (single-day, two doses) and MAD (7-day, twice-daily dosing); cohorts randomised 5:2 active:placebo.

Participants are admitted prior to dosing and remain until Day 3 (SAD) or Day 9 (MAD). Follow-up visits occur through Day 28 (SAD) or Day 42 (MAD). Safety and PK assessments include vitals, labs, AE monitoring and plasma PK up to 48 hours after dosing.

Study Arms & Interventions

18-MC SAD

experimental

Part 1 (SAD): cohorts randomised to 18-MC HCl or placebo; two doses in 1 day.

Interventions

  • Compound
    via Oral• two doses in 1 day (bid)• 2 doses total

    18-MC HCl; cohorts randomised 5:2 active:placebo

18-MC MAD

experimental

Part 2 (MAD): cohorts randomised to 18-MC HCl or placebo; two doses daily for 7 days.

Interventions

  • Compound
    via Oral• two doses daily for 7 days (bid)• 14 doses total

    18-MC HCl; cohorts randomised 5:2 active:placebo

Participants

Ages
18 – 55
Sexes
Male & Female

Inclusion Criteria

  • 1. Written informed consent before any study-specific procedures.
  • 2. Healthy male and female volunteers aged 18 to 55 years (inclusive) with suitable veins for cannulation and repeated venipuncture.
  • 3. Female subjects of both childbearing and nonchildbearing potential will be considered, with certain conditions met.
  • 4. Female subjects must agree not to breastfeed starting at screening and throughout the study period.
  • 5. Male participants must agree to practice abstinence; be surgically sterilized; or agree to use of a condom, plus effective contraception.
  • 6. Have not smoked or used any tobacco or nicotine-containing products in the 3 months before screening and agree not to smoke during the entire study.

Exclusion Criteria

  • 1. History of any clinically important disease or disorder that, in the opinion of the investigator, would affect the ability of the participant to participate in the study.
  • 2. History or presence of gastrointestinal, hepatic, cardiac, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of study drug.
  • 3. History of gastrointestinal ulcer disease, inflammatory bowel disease, or frequent indigestion symptoms.
  • 4. Adequate organ function.
  • 5. History of seizures or epilepsy.
  • 6. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV).
  • 7. Any clinically significant cardiovascular abnormalities.
  • 8. Known or suspected history of substance abuse disorder.
  • 9. History of alcohol abuse or excessive intake of alcohol.
  • 10. Positive screen for drugs of abuse, cotinine (nicotine) or alcohol.
  • 11. Has received another new chemical entity (defined as a compound, which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 30 days.

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment108 participants
  • Timeline
    Start: 2020-04-14
    End: 2022-01-15
  • Topic
    Substance Use Disorders (SUD)

Locations

Dr. Sam Salman — Perth, Australia

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