This is a single-centre phase I study to assess the Drug-Drug Interaction potential of MLC1501 with a cocktail of drugs acting as sensitive clinical probe substrates of Cytochrome P450 isoenzymes and Transporters in healthy subjects . The study will have 2 cohorts, one for the CYP study and the other for the Transporters study. Eligible subjects (n=24) will be assigned to one of the 2 cohorts in a 1:1 ratio.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
27
MLC1501 capsules (4 capcules (2000 mg) twice a day)
Repaglinide 0.25 mg, caffeine 100 mg, warfarin 10 mg (with vitamin K), omeprazole 40 mg, dextromethorphan 30 mg, midazolam 2 mg
Digoxin 0.25 mg, furosemide 1 mg, metformin 10 mg, rosuvastatin 10 mg
Nucleus Network
Melbourne, Victoria, Australia
Change in area under curve (AUC) of individual substrates is being assessed between cocktail alone and cocktail + MLC1501 administration
Assayed in plasma samples collected at various time points after cocktail administration and cocktail + MLC1501 administration.
Time frame: Through study completion, an average of 29 days and 18 days for CYP and Transporter cohort, respectively.
Change in maximum concentration (Cmax) of individual substrates is being assessed between cocktail alone and cocktail + MLC1501 administration
Assayed in plasma samples collected at various time points after cocktail administration and cocktail + MLC1501 administration.
Time frame: Through study completion, an average of 29 days and 18 days for CYP and Transporter cohort, respectively.
Change in time taken to reach maximum concentration (Tmax) of individual substrates is being assessed between cocktail alone and cocktail + MLC1501 administration
Assayed in plasma samples collected at various time points after cocktail administration and cocktail + MLC1501 administration.
Time frame: Through study completion, an average of 29 days and 18 days for CYP and Transporter cohort, respectively.
Ratio of geometric means (GMR) between cocktail alone and cocktail + MLC1501 for the AUC and Cmax of the corresponding probe
Time frame: Through study completion, an average of 29 days and 18 days for CYP and Transporter cohort, respectively.
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