The aim of the study is to assess how MIN-101 is taken up by the body when given in different amounts and in different formulations. The drug will be given as a single dose in Part 1 of the study and during Part 2 of the study as multiple dose, once daily for 7 days. The ultimate aim is to find an optimal formulation which can be developed as a once daily dose for the treatment of schizophrenia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Enrollment
32
Quotient Clinical
Ruddington, Nottingham, United Kingdom
Part 1 Pharmacokinetic profile of MIN-101 and its main metabolites (AUC (0-last), Tmax, Cmax, AUC (0-inf), %AUCextrap, Lambda z, T1/2 and parent:metabolites ratio
Time frame: predose and 0.5h, 1h, 1.5h, 2h, 2.5h, 3H, 4H, 6h, 8h, 10h, 12h, 14h, 16h, 20h, 24h, 48h and 72h post-dose
Part 2 - Pharmacokinetic profile of MIN-101 and its main metabolites - Absolute QT intervals and QT intervals corrected using Fridericia formula (QTcF)
Time frame: predose to Day 8
Part 1 Safety and tolerability (incidence of adverse events, safety laboratory, 12-lead ECGs, vital signs, physical examination) -
Time frame: from predose up to 72 h post dosing
Part 1 Pharmacokinetic profile of MIN-101 in fed and fasted state
Time frame: from predose up to 72 h post dosing
Part 2 Change from baseline in ECG parameters other than QT/QTc
QTcB, QRS, RR, PR intervals, U waves, T waves morphology
Time frame: from predose up to Day 8
Part 2 Change from baseline in heart rate and blood pressure
Time frame: from predose up to Day 8
Part 2 Incidence of QT/QTc changes from baseline greater than 30 and 60 ms post dose
Time frame: from predose up to Day 8
Part 2 Incidence of QTc values greater than 450, 480 and 500 ms post dose
Time frame: from predose up to Day 8
Part 2 Safety and tolerability of MIN-101 (adverse events occurrence, physical examination, safety laboratory tests)
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Time frame: from predose up to Day 8