A Study to Assess 18-Methoxycoronaridine (18-MC... — Clinical Trial Details

Phase 1, double-blind, randomized, placebo-controlled study in healthy non-smoking adults. Two parts: SAD (single-day, two doses) and MAD (7-day, twice-daily dosing); cohorts randomised 5:2 active:placebo.

Participants are admitted prior to dosing and remain until Day 3 (SAD) or Day 9 (MAD). Follow-up visits occur through Day 28 (SAD) or Day 42 (MAD). Safety and PK assessments include vitals, labs, AE monitoring and plasma PK up to 48 hours after dosing.

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.

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.

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

Detailed Description

Study Arms & Interventions

18-MC SAD

Interventions

18-MC MAD

Interventions

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Participants

Inclusion Criteria

Exclusion Criteria

Study Details

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