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

NCT ID: NCT03482817

Last Updated: 2018-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-05
• Study Completion Date: 2018-06-23

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Probe drug cocktail / Ze 117

One-sequence, Probe drug cocktail alone and in combination with Ze 117.

Group Type: EXPERIMENTAL

Ze 117

Intervention Type: DRUG

Subjects will be hospitalized to receive a probe drug cocktail alone and in combination with Ze 117.

Probe drug cocktail

Intervention Type: DRUG

Subjects will be hospitalized to receive a probe drug cocktail alone and in combination with Ze 117.

Interventions

Ze 117

Subjects will be hospitalized to receive a probe drug cocktail alone and in combination with Ze 117.

Intervention Type: DRUG

Probe drug cocktail

Subjects will be hospitalized to receive a probe drug cocktail alone and in combination with Ze 117.

Intervention Type: DRUG

Other Intervention Names

St. John's wort dry extract Ze 117

Eligibility Criteria

Inclusion Criteria

• written informed consent
• Caucasian male or female subjects aged between ≥18 and ≤55years
• Physically and mentally healthy
• BMI between ≥19 and ≤29 kg/m2, and body weight ≤90 kg
• Non-smoker
• If female, the pregnancy test at screening and at admission must be negative

Exclusion Criteria

• Known or suspected hypersensitivity to study drugs
• history of, any clinically significant diseases
• Positive test of hepatitis B, hepatitis C or HIV Screening
• Known photohypersensitivity

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Max Zeller Soehne AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Lissy

Role: PRINCIPAL_INVESTIGATOR

Neu-Ulm

Locations

Nuvisan GmbH

Neu-Ulm, , Germany

Countries

Germany

Other Identifiers

Ze117-1-2017-01

Identifier Type: -

Identifier Source: org_study_id