NCT03482817

Drug Cocktail Interaction Study of St. John's Wort Dry Extract Ze 117

Drug Cocktail Interaction Study to Investigate the Effect of St. John's Wort Dry Extract Ze 117 on Several Cytochrome P450 Enzymes and on Transporter P-Glycoprotein in Healthy Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Max Zeller Soehne AG · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This Study evaluates the Effect of St. John's Wort dry Extract Ze 117 on Several Cytochrome P450 Enzymes and on Transporter P-Glycoprotein in Healthy Volunteers.

Detailed description

Current data indicate that St. John's wort preparations may induce hepatic cytochrome P450 enzymes and transport proteins. This can result in drug interactions. The study design is standard for DDI studies and is based on the regulatory guidance of the Food and Drug Administration (FDA) and of the European Medicines Agency (EMA). A cocktail approach involving the administration of multiple cytochrome P450 (CYP)- or P-glycoprotein (P-gp)-specific probe drugs is used to simultaneously assess the activities of these enzymes and the transporter P-gp.

Conditions

• Drug Interaction Study

Interventions

Type	Name	Description
DRUG	Ze 117	Subjects will be hospitalized to receive a probe drug cocktail alone and in combination with Ze 117.
DRUG	Probe drug cocktail	Subjects will be hospitalized to receive a probe drug cocktail alone and in combination with Ze 117.

Timeline

• Start date: 2018-02-05
• Primary completion: 2018-05-17
• Completion: 2018-06-23
• First posted: 2018-03-29
• Last updated: 2018-03-29

Locations

1 site across 1 country: Germany