NCT03482817

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2018

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2018

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2018

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

3 months

First QC Date

February 26, 2018

Last Update Submit

March 22, 2018

Conditions

Drug Interaction Study

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Area under the Plasma concentration versus time curve (AUC0-inf)

    72 hours

  • Peak Plasma Concentration (Cmax)

    72 hours

  • Elimination rate constant (Ke)

    72 hours

  • Elimination half life (t1/2)

    72 hours

Study Arms (1)

Probe drug cocktail / Ze 117

EXPERIMENTAL

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

Drug: Ze 117Drug: Probe drug cocktail

Interventions

Ze 117DRUG

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 cocktailDRUG

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

Probe drug cocktail / Ze 117

Eligibility Criteria

Age18 Years - 55 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsCaucasian
Healthy VolunteersYes
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nuvisan GmbH

Neu-Ulm, Germany

Location

MeSH Terms

Interventions

ZE 117

Study Officials

  • Michael Lissy

    Neu-Ulm

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: open-label, non-randomized, single-sequence study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

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

March 29, 2018

Record last verified: 2018-03

Locations

DE(1)