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

NCT03482817 | Completed Phase 1 Results

• 1 other identifier: Ze117-1-2017-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Interaction Study

Outcome Measures

Primary Outcomes (1)

• Ratio AUC0-t, Day 17 (Probe Drug Cocktail Plus Ze117 [Only at Day 17]) vs. Day 1 (Probe Drug Cocktail Alone)

  The "number" as provided in the tables is the ratio (in %) of geometric LS means of AUC of day 17 dosing samples (probe drug cocktail plus Ze117) vs. Day 1 dosing samples (probe drug cocktail alone). A one-way ANOVA model (with terms for subject and treatment) was applied to analyze the effect of Ze117 on the respective probe drug. Log transformed (base e) parameters were used within the model. The estimated treatment difference between day 17 and day 1 was transformed back to original scale and presented as the ratio between treatments including the corresponding 90% confidence interval. Effect limits were predefined as follows: (1) Mild effect limits (50-200%), extended bioequivalence limits (70-143%), bioequivalence limits (80-125%).

  PK samples: pre-dose, and 10, 20, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours after each cocktail administration (at day 1 and day 17)

Secondary Outcomes (3)

• Ratio AUC0-t, Day 8 (Probe Drug Cocktail Plus Ze117 [Daily Throughout pk Sampling Period]) vs. Day 1 (Probe Drug Cocktail Alone)

  PK samples: pre-dose, and 10, 20, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours after each cocktail administration (at day 1 and day 8)

• Ratio Cmax, Day 17 (Probe Drug Cocktail Plus Ze117 [Only at Day 17]) vs. Day 1 (Probe Drug Cocktail Alone)

  PK samples: pre-dose, and 10, 20, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours after each cocktail administration (at day 1 and day 17)

• Ratio Cmax, Day 8 (Probe Drug Cocktail Plus Ze117 [Daily Throughout pk Sampling Period]) vs. Day 1 (Probe Drug Cocktail Alone)

  PK samples: pre-dose, and 10, 20, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours after each cocktail administration (at day 1 and day 8)

Study Arms (1)

Probe drug cocktail / Ze 117

EXPERIMENTAL

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

Drug: Ze 117; Drug: Probe drug cocktail

Interventions

Ze 117 DRUG

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

Also known as: St. John's wort dry extract Ze 117

Probe drug cocktail / Ze 117

Probe drug cocktail DRUG

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

Probe drug cocktail / Ze 117

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Caucasian
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Max Zeller Soehne AG: lead

Study Sites (1)

Nuvisan GmbH

Neu-Ulm, Germany

Location

MeSH Terms

Interventions

ZE 117

Results Point of Contact

• Title: Prof. Dr. Veronika Butterweck
• Organization: Max Zeller Söhne AG

veronika.butterweck@zellerag.ch

0041714660447

Study Officials

• Michael Lissy

  Neu-Ulm

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: open-label, non-randomized, single-sequence study

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 29, 2018
• Study Start: February 5, 2018
• Primary Completion: May 17, 2018
• Study Completion: June 23, 2018
• Last Updated: June 18, 2026
• Results First Posted: June 18, 2026

Record last verified: 2026-05

Locations

DE (1)