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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04292197




Registration number
NCT04292197
Ethics application status
Date submitted
18/02/2020
Date registered
3/03/2020
Date last updated
12/03/2021

Titles & IDs
Public title
A Study to Assess 18-Methoxycoronaridine
Scientific 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
Secondary ID [1] 0 0
MMED003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Addiction 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 18-MC Compound

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.

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.


Treatment: Drugs: 18-MC Compound
18-MC

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess the safety, using incidence and severity of adverse events, of a single and multiple-day dosing of 18-MC administered orally. - 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.
Timepoint [1] 0 0
Up to 28 days (SAD) and 42 days (MAD)
Secondary outcome [1] 0 0
Maximum Observed Plasma Concentration (Cmax) - Blood samples for determination of study drug (18-MC) concentration parameters at various timepoints
Timepoint [1] 0 0
48 post dose - Day 1 and Day 7
Secondary outcome [2] 0 0
Time to Reach Maximum Observed Plasma Concentration (Tmax) - Blood samples for determination of study drug (18-MC) parameters at various timepoints
Timepoint [2] 0 0
48 hours post dose - Day 1 and Day 7
Secondary outcome [3] 0 0
Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast) - Blood samples for determination of study drug (18-MC) parameters at various timepoints
Timepoint [3] 0 0
AUC(t0-48hr) pg*hr/mL
Secondary outcome [4] 0 0
Terminal Elimination Half-Life (t1/2) - Blood samples for determination of study drug (18-MC) concentration parameters at various timepoints
Timepoint [4] 0 0
48 hours post dose - Day 1 and Day 7
Secondary outcome [5] 0 0
Lambda z (1/T1/2) - Blood samples for determination of study drug (18-MC) concentration parameters at various timepoints
Timepoint [5] 0 0
48 hours post dose - Day 1 and Day 7
Secondary outcome [6] 0 0
As an exploratory objective, the concentration of metabolites in plasma and urine may be determined - Plasma and urine samples for determination of study drug concentrations at various timepoints
Timepoint [6] 0 0
Up to 28 days (SAD) and 42 days (MAD)

Eligibility
Key inclusion criteria
Key

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
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Dr. Sam Salman - Perth
Recruitment postcode(s) [1] 0 0
- Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Mind Medicine, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04292197
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Rob Barrow
Address 0 0
Country 0 0
Phone 0 0
+1 212-220-6633
Fax 0 0
Email 0 0
clinicaltrials@mindmed.co
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04292197