Overview

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

Status:
Recruiting
Trial end date:
2022-02-07
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Mind Medicine, Inc.
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