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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Moleac Pte Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Stroke

Interventions

Type	Name	Description
DRUG	MLC1501	MLC1501 capsules (4 capcules (2000 mg) twice a day)
DRUG	CYP Cocktail	Repaglinide 0.25 mg, caffeine 100 mg, warfarin 10 mg (with vitamin K), omeprazole 40 mg, dextromethorphan 30 mg, midazolam 2 mg
DRUG	Transporter Cocktail	Digoxin 0.25 mg, furosemide 1 mg, metformin 10 mg, rosuvastatin 10 mg

Timeline

• Start date: 2020-02-10
• Primary completion: 2020-05-16
• Completion: 2020-05-16
• First posted: 2020-01-18
• Last updated: 2020-09-03

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study