drugset / Trial / NCT04233437
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
Non-randomizedParallel-groupOpen-labelOther
Summary
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.
Timeline
- Start
- 2020-02-10
- Primary completion
- 2020-05-16
- Completion
- 2020-05-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Caffeine | Small molecule | 100 mg | — |
| Subject | Dextromethorphan | Unknown | 30 mg | — |
| Subject | Digoxin | Other / unclassified | 0.25 mg | — |
| Subject | Furosemide | Other / unclassified | 1 mg | — |
| Subject | MLC1501 | Traditional medicine (herbal / TCM) | 2000 mg | — |
| Subject | Metformin | Small molecule | 10 mg | — |
| Subject | Midazolam | Small molecule | 2 mg | — |
| Subject | Omeprazole | Other / unclassified | 40 mg | — |
| Subject | Repaglinide | Small molecule | 0.25 mg | — |
| Subject | Rosuvastatin | Small molecule | 10 mg | — |
| Subject | Warfarin | Small molecule | 10 mg | — |
| Background | Vitamin K | Unknown | — | — |