Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04292197
Ethics application status
Date submitted
18/02/2020
Date registered
3/03/2020
Date last updated
5/01/2022

Titles & IDs
Public title
A Study to Assess 18-Methoxycoronaridine (18-MC HCl) in Healthy Volunteers
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 (18-MC HCl) 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

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.

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.


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.
Timepoint [1] 0 0
Up to 28 days (SAD) and 42 days (MAD)
Secondary outcome [1] 0 0
Maximum Observed Plasma Concentration (Cmax)
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)
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)
Timepoint [3] 0 0
AUC(t0-48hr) pg*hr/mL
Secondary outcome [4] 0 0
Terminal Elimination Half-Life (t1/2)
Timepoint [4] 0 0
48 hours post dose - Day 1 and Day 7
Secondary outcome [5] 0 0
As an exploratory objective, the concentration of metabolites in plasma and urine may be determined
Timepoint [5] 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
Sex
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 analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/04/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2021
Sample size
Target
Accrual to date
Final
108
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/study/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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

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