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

CompletedRegisteredCTG

The primary objective of this Phase 1 double-blind, randomized, placebo-controlled study in healthy non-smoking volunteers is to assess safety and tolerability of single-day (SAD) and multiple-day (MAD) oral dosing of 18-MC HCl.

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.

Topics:Substance Use Disorders (SUD)

Registry

Registry linkNCT04292197