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

Max Zeller Söhne

Status and phase: Unknown; Phase 1

Conditions: Drug Interaction Study

Treatments: Drug: Probe drug cocktail; Drug: Ze 117

Study type: Interventional

Funder types: Industry

Identifiers

NCT03482817

Ze117-1-2017-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Probe drug cocktail / Ze 117

Experimental group

Description:

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

Treatment:

Drug: Ze 117

Drug: Probe drug cocktail