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A Study to Assess 18-Methoxycoronaridine

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ClinicalTrials.gov Identifier: NCT04292197
Recruitment Status : Recruiting
First Posted : March 3, 2020
Last Update Posted : February 11, 2021
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 day dosing

Seven (7) healthy male and female volunteers will be randomly assigned to receive in a single day either 18-MC HCl (n=5) or placebo (n=2) in each cohort. There will be 10 cohorts:

  1. 4 mg twice a day (bid) for 1 day
  2. 8 mg twice a day (bid) for 1 day
  3. 12 mg twice a day (bid) for 1 day
  4. 16 mg twice a day (bid) for 1 day
  5. 25 mg twice a day (bid) for 1 day
  6. 40 mg twice a day (bid) for 1 day
  7. 75 mg twice a day (bid) for 1 day
  8. 150 mg twice a day (bid) for 1 day
  9. 300 mg twice a day (bid) for 1 day
  10. 600 mg twice a day (bid) for 1 day

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 dosing

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. There will be up to 6 cohorts:

  1. 2 mg twice a day (bid) for 7 days
  2. 5 mg twice a day (bid) for 7 days
  3. 10 mg twice a day (bid) for 7 days
  4. TBD mg twice a day (bid) for 7 days
  5. TBD mg twice a day (bid) for 7 days
  6. TBD mg twice a day (bid) for 7 days

The proposed dosages for the TBD MAD Cohorts will be determined upon completion of the SAD cohorts.

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)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, 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 Administered Orally to Normal Healthy Volunteers
Actual Study Start Date : April 14, 2020
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : April 30, 2021

Arm Intervention/treatment
Placebo Comparator: 18-MC SAD Study
In Part 1, seventy (70) healthy participants will be randomized in 6 cohorts to receive a bid dose of 18-MC HCl (n=50) or placebo (n=20) in a single day.
Drug: 18-MC Compound
18-MC

Experimental: 18-MC MAD Study (7-Day)
In Part 2, up to forty-two (42) healthy participants will be randomized in up to 6 cohorts to receive a bid dose of 18-MC HCl (n=30) or placebo (n=12) 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. Lambda z (1/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

  6. 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


Contacts
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Contact: Rob Barrow +1 212-220-6633 clinicaltrials@mindmed.co

Locations
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Australia
Dr. Sam Salman Recruiting
Perth, Australia
Contact: Sam Salman         
Contact: Liisa Bevan         
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: February 11, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Behavior, Addictive
Compulsive Behavior
Impulsive Behavior