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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04292197
Recruitment Status : Completed
First Posted : March 3, 2020
Last Update Posted : January 5, 2022
Sponsor:
Information provided by (Responsible Party):
Mind Medicine, Inc.

Brief Summary:
The primary objective of this study is to assess the safety and tolerability of a single day dosing and a separate multiple day dosing of 18-MC HCl administered orally, each part of the study having a different set of healthy male and female volunteers.

Condition or disease Intervention/treatment Phase
Addiction Drug: 18-MC Compound Phase 1

Detailed Description:

This is a Phase 1, double-blind, randomized, placebo-controlled, single day and multiple day dosing, in healthy, non-smoking, male and female volunteers.

Part 1: Single Ascending Dose (SAD)

Seven (7) healthy male and female volunteers will be randomly assigned to receive either 18-MC HCl (n=5) or placebo (n=2) in each cohort. These volunteers will receive 18-MC HCl twice in 1 day (bid).

There are 3 phases: Screening, Enrollment and Follow-Up. All participants will be assessed for safety and tolerability for 28 days. Screening begins when a participant reports to the clinical unit (CU) for a screening visit to undergo safety and compliance assessments on this day. Participants that meet all eligibility criteria will be admitted to the CU on the day prior to receiving study drug. Enrollment begins on Day 1 where participants will receive two doses of study drug for 1 day, will be assessed for 18-MC PK up to 48 hours, and will remain admitted at the CU until Day 3, at which time they will be discharged. For follow-up the participants will return for safety and tolerability assessments at Days 7, 14, 21 and Day 28.

Part 2: Multiple Day Ascending Dose (MAD)

Seven (7) healthy male and female volunteers will be randomly assigned to receive either 18-MC HCl (n=5) or placebo (n=2) in each cohort. These volunteers will receive 18-MC HCl twice over 7 days (bid).

There are 3 phases: Screening, Enrollment and Follow-Up. All participants will be assessed for 42 days. Screening begins when a participant reports to the clinical unit (CU) for a screening visit to undergo safety and compliance assessments on this day. Participants that meet all eligibility criteria will be admitted to the CU on the day prior to receiving study drug. Enrollment begins on Day 1 where participants will receive two doses of study drug every day for 7 days, will be assessed for 18-MC PK up to 48 hours on Day 1 and Day 7, and will remain admitted at the CU until Day 9, at which time they will be discharged. For follow-up the participants will return for safety and tolerability assessments at Days 14, 21, 28, 35 and Day 42.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single/Multiple Day Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of 18- Methoxycoronaridine (18-MC HCl) Administered Orally to Normal Healthy Volunteers
Actual Study Start Date : April 14, 2020
Actual Primary Completion Date : December 13, 2021
Actual Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: 18-MC SAD Study
In Part 1, healthy participants will be randomized into cohorts to receive 18-MC HCl or placebo twice in 1 day.
Drug: 18-MC Compound
18-MC

Experimental: 18-MC MAD Study
In Part 2, healthy participants will be randomized into cohorts to receive 18-MC HCl or placebo twice a day for 7 consecutive days.
Drug: 18-MC Compound
18-MC




Primary Outcome Measures :
  1. To assess the safety, using incidence and severity of adverse events, of a single and multiple-day dosing of 18-MC administered orally. [ Time Frame: Up to 28 days (SAD) and 42 days (MAD) ]
    Safety and tolerability will be assessed by the incidence and severity of adverse events (AEs). An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.


Secondary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 48 post dose - Day 1 and Day 7 ]
    Blood samples for determination of study drug (18-MC) concentration parameters at various timepoints

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 48 hours post dose - Day 1 and Day 7 ]
    Blood samples for determination of study drug (18-MC) parameters at various timepoints

  3. Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: AUC(t0-48hr) pg*hr/mL ]
    Blood samples for determination of study drug (18-MC) parameters at various timepoints

  4. Terminal Elimination Half-Life (t1/2) [ Time Frame: 48 hours post dose - Day 1 and Day 7 ]
    Blood samples for determination of study drug (18-MC) concentration parameters at various timepoints

  5. As an exploratory objective, the concentration of metabolites in plasma and urine may be determined [ Time Frame: Up to 28 days (SAD) and 42 days (MAD) ]
    Plasma and urine samples for determination of study drug concentrations at various timepoints



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key 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.

Key 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04292197


Locations
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Australia
Dr. Sam Salman
Perth, Australia
Sponsors and Collaborators
Mind Medicine, Inc.
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Responsible Party: Mind Medicine, Inc.
ClinicalTrials.gov Identifier: NCT04292197    
Other Study ID Numbers: MMED003
First Posted: March 3, 2020    Key Record Dates
Last Update Posted: January 5, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mind Medicine, Inc.:
opioid use disorder (OUD)
Additional relevant MeSH terms:
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Behavior, Addictive
Compulsive Behavior
Impulsive Behavior