* To evaluate the pharmacokinetic (PK) profiles of MIN-l0l following administration of modified release (MR) formulations of MIN-l0l in healthy male and female subjects * To select 1 MR formulation for use in fed state * To evaluate the effect of food on the bioavailability of MIN-l0l selected MR formulation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
14
Biokinetic Europe
Belfast, Ireland
Part 1: Plasma PK parameter, Cmax
To estimate the relative bioavailability of MIN-l0l following MIN-101 administration. Plasma samples will be analyzed for MIN-101 and its metabolites using a validated LC-MS/MS method
Time frame: from predose up to 72 hours post dose: Blood samples for MIN-101 will be collected at time 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 48, 60, and 72 hours post-dose on Day 1 of all periods.
Part 1: Plasma PK parameter, Tmax
Time frame: from predose up to 72 hours post dose
Part 1: Plasma PK parameter, Tlag
Time frame: from predose up to 72 hours post dose
Part 1: Plasma PK parameter,partial AUC (e.g., AUC12, AUC24), AUClast, AUC∞
Time frame: from predose up to 72 hours post dose
Part 1: Plasma PK parameter, λz and t1/2
Time frame: from predose up to 72 hours post dose
Part 2: Plasma PK parameter, Cmax
To estimate the relative bioavailability of MIN-101 and its main metabolites following the administration of the selected modified release formulation in different food conditions (fasted or fed state).
Time frame: from predose up to 72 hours post dose: Blood samples for MIN-101 will be collected at time 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 48, 60, and 72 hours post-dose on Day 1 of all periods.
Part 2: Plasma PK parameter, Tmax
Time frame: from predose up to 72 hours post dose
Part 2: Plasma PK parameter, Tlag
Time frame: from predose up to 72 hours post dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Part 2: Plasma PK parameter, λz and t1/2
Time frame: from predose up to 72 hours post dose
Part 1: QTcF changes from baseline
The effect of coincidentally measured (time-matched) plasma concentrations of MIN-l0l on QTcF changes from Baseline.
Time frame: from predose up to 72 hours post dose
Part 1: Safety (AE reporting, safety laboratory parameters analysis, vital signs and 12 lead ECG assessments)
Safety will be assessed through AE reporting, safety laboratory parameters analysis, vital signs and 12 lead ECG assessments
Time frame: 2 months 16 days
Part 2: Safety (AE reporting, safety laboratory parameters analysis, vital signs and 12 lead ECG assessments)
Safety will be assessed through AE reporting, safety laboratory parameters analysis, vital signs and 12 lead ECG assessments
Time frame: 2 months 16 days