Drug-Drug Interaction Study of MLC1501 Using Cocktail of Drugs Acting as Sensitive Clinical Probes/Substrates of Cytochrome P450 Isoenzymes and Transporters in Healthy Subjects
Abstract
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.
Conditions: Stroke.
Primary outcome: Change in area under curve (AUC) of individual substrates is being assessed between cocktail alone and cocktail + MLC1501 administration; Change in maximum concentration (Cmax) of individual substrates is being assessed between cocktail alone and cocktail + MLC1501 administration; Change in time taken to reach maximum concentration (Tmax) of individual substrates is being assessed between cocktail alone and cocktail + MLC1501 administration.
Enrollment: 27 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 27 participants or records.
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