The purpose of this Phase 1 single ascending dose (SAD) study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamic profile of MSD-001 when administered orally to healthy adult participants.
This is a first in human, prospective, single center, double blind, placebo-controlled, single ascending dose study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MSD-001. The study will include two parallel parts, Part 1 and Part 2, stratified by CYP2D6 phenotype.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
47
MSD-001 is being developed as part of future two-agent combination treatment approaches for the management of mental health indications
Matching Placebo
Centre for Human Drug Research
Leiden, South Holland, Netherlands
Assess the safety and tolerability of MSD-001 in healthy adult participants by assessing the number, duration, severity, drug relatedness and type of adverse events
Treatment emergent adverse events/ treatment emergent serious adverse events - their frequency, duration and severity, clinically significant changes in lab parameters, ECG, and vital signs
Time frame: up to 30 days
Plasma Pharmacokinetics (PK) of a single dose of MSD-001: Maximum Plasma Concentration (Cmax)
Following completion of each cohort, bioanalytical analysis for MSD-001 serial PK timepoints will be performed and plasma PK parameters for Cmax analyzed
Time frame: Pre-dose and up to 24 hours post dose
Plasma Pharmacokinetics (PK) of a single dose of MSD-001: time to attain Cmax (Tmax)
Following completion of each cohort, bioanalytical analysis for MSD-001 serial PK will be performed and plasma PK parameters for Tmax analyzed
Time frame: Pre-dose and up to 24 hours post dose
Plasma Pharmacokinetics (PK) of a single dose of MSD-001: Area under plasma Concentration (AUC)
Following completion of each cohort, bioanalytical analysis for MSD-001 serial PK timepoints will be performed and plasma PK parameters for AUC analyzed
Time frame: Pre-dose and up to 24 hours post dose
Plasma Pharmacokinetics (PK) of a single dose of MSD-001: terminal elimination half-life (T1/2)
Following completion of each cohort, bioanalytical analysis for MSD-001 serial PK will be performed and plasma PK parameters for T1/2 analyzed
Time frame: Pre-dose and up to 24 hours post dose
5D-ASC (5 dimensional altered states of consciousness) rating scale (a 94-item VAS questionnaire)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Participants will be asked to reflect on the previous days' subjective experience using 5D-ASC rating scale.
Time frame: Pre-dose and 24 hours post dose