Status:
COMPLETED
A Study to Assess 18-Methoxycoronaridine (18-MC HCl) in Healthy Volunteers
Lead Sponsor:
Mind Medicine, Inc.
Conditions:
Addiction
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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...
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...
Eligibility Criteria
Inclusion
- Key
- Written informed consent before any study-specific procedures.
- Healthy male and female volunteers aged 18 to 55 years (inclusive) with suitable veins for cannulation and repeated venipuncture.
- Female subjects of both childbearing and nonchildbearing potential will be considered, with certain conditions met
- Female subjects must agree not to breastfeed starting at screening and throughout the study period.
- Male participants must agree to practice abstinence; be surgically sterilized; or agree to use of a condom, plus effective contraception.
- 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
- 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
- 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.
- History of gastrointestinal ulcer disease, inflammatory bowel disease, or frequent indigestion symptoms
- Adequate organ function
- History of seizures or epilepsy.
- Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV).
- Any clinically significant cardiovascular abnormalities
- Known or suspected history of substance abuse disorder
- History of alcohol abuse or excessive intake of alcohol
- Positive screen for drugs of abuse, cotinine (nicotine) or alcohol
- 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
Key Trial Info
Start Date :
April 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT04292197
Start Date
April 14 2020
End Date
December 31 2021
Last Update
January 5 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Dr. Sam Salman
Perth, Australia