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

Drug Interaction Study Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03482817
• Other study ID #: Ze117-1-2017-01
• Status: Enrolling by invitation
• Phase: Phase 1
• First received: February 26, 2018
• Last updated: March 22, 2018
• Start date: February 5, 2018
• Est. completion date: June 23, 2018

Study information

• Verified date: March 2018
• Source: Max Zeller Soehne AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: June 23, 2018
• Est. primary completion date: May 17, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Interaction Study

Intervention

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

Locations

Country	Name	City	State
Germany	Nuvisan GmbH	Neu-Ulm

Sponsors (1)

Lead Sponsor	Collaborator
Max Zeller Soehne AG

Country where clinical trial is conducted

Germany, 

Outcome

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