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

Phase 1

• Conditions: Drug Interaction Study
• Interventions: Drug: Ze 117; Drug: Probe drug cocktail

• Registration Number: NCT03482817
• Lead Sponsor: Max Zeller Soehne AG

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.

Study Timeline

• Study Start: 2018-02-05
• Study First Submitted: 2018-02-26
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-22
• Last Update Submitted: 2018-03-22
• Study First Posted: 2018-03-29
• Last Update Posted: 2018-03-29
• Primary Completion: 2018-05-17
• Study Completion: 2018-06-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Probe drug cocktail / Ze 117	Ze 117	One-sequence, Probe drug cocktail alone and in combination with Ze 117.
Probe drug cocktail / Ze 117	Probe drug cocktail	One-sequence, Probe drug cocktail alone and in combination with Ze 117.

Primary Outcome Measures

Name	Time	Method
Area under the Plasma concentration versus time curve (AUC0-t)	72 hours	Pharmacokinetic Parameter AUC0-t (mg\*h/L) of the probe drugs will be determined.

Secondary Outcome Measures

Name	Time	Method
Elimination rate constant (Ke)	72 hours	Pharmacokinetic Parameter (h\^-1) of the probe drugs and their metabolites will be determined.
Peak Plasma Concentration (Cmax)	72 hours	Pharmacokinetic Parameter (ng/ml) of the probe drugs and their metabolites will be determined.
Elimination half life (t1/2)	72 hours	Pharmacokinetic Parameter (h) of the probe drugs and their metabolites will be determined.
Area under the Plasma concentration versus time curve (AUC0-inf)	72 hours	Pharmacokinetic parameter (mg\*h/L) of the probe drugs and their metabolites will be determined.

Trial Locations

Locations (1)

Nuvisan GmbH; 🇩🇪 Neu-Ulm, Germany