This is a two-part randomized, double-blind, placebo-controlled study.
This is a two-part randomized, double-blind, placebo-controlled study. The study comprises a SAD (Part 1) assessment which will include a food effect assessment that contributes data to inform a subsequent MAD (Part 2) dose-ranging study. Safety measurements will be collected throughout the study for all subjects. Blood samples will be collected to determine the PK parameters of SRP-3D (DA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL
Matching Placebo for SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL
Quotient Sciences-Miami, Inc.
Miami, Florida, United States
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Reported AEs
Time frame: The time of providing written informed consent until 30 days after the last dose of study drug
PK parameters 1
Lag time (Tlag)
Time frame: 6 days
PK parameters 2
Time to reach maximum (peak) plasma concentration following drug administration (Tmax)
Time frame: 6 days
PK parameters 3
Maximum (peak) plasma drug concentration (Cmax)
Time frame: 6 days
PK parameters 4
Area under the plasma concentration-time curve from time zero to infinity (AUCinf)
Time frame: 6 days
PK parameters 5
Area under the plasma concentration-time curve from time zero to infinity (AUClast)
Time frame: 6 days
PK parameters 6
Area under the plasma concentration-time curve (AUC0-tau)
Time frame: 6 days
PK parameters 7
Terminal disposition rate constant/terminal rate constant (λz)
Time frame: 6 days
PK parameters 8
Elimination half-life (T1/2)
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Time frame: 6 days
PK parameters 9
Apparent total clearance of the drug from plasma after oral administration (CL/F)
Time frame: 6 days
PK parameters 10
Apparent volume of distribution during terminal phase after non-intravenous administration (Vz/F)
Time frame: 6 days