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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03482817
Recruitment Status : Unknown
Verified March 2018 by Max Zeller Soehne AG.
Recruitment status was:  Enrolling by invitation
First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Drug Interaction Study Drug: Ze 117 Drug: Probe drug cocktail Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: open-label, non-randomized, single-sequence study
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 5, 2018
Estimated Primary Completion Date : May 17, 2018
Estimated Study Completion Date : June 23, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: Probe drug cocktail / Ze 117
One-sequence, Probe drug cocktail alone and in combination with Ze 117.
Drug: Ze 117
Subjects will be hospitalized to receive a probe drug cocktail alone and in combination with Ze 117.
Other Name: St. John's wort dry extract Ze 117

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




Primary Outcome Measures :
  1. Area under the Plasma concentration versus time curve (AUC0-t) [ Time Frame: 72 hours ]
    Pharmacokinetic Parameter AUC0-t (mg*h/L) of the probe drugs will be determined.


Secondary Outcome Measures :
  1. Area under the Plasma concentration versus time curve (AUC0-inf) [ Time Frame: 72 hours ]
    Pharmacokinetic parameter (mg*h/L) of the probe drugs and their metabolites will be determined.

  2. Peak Plasma Concentration (Cmax) [ Time Frame: 72 hours ]
    Pharmacokinetic Parameter (ng/ml) of the probe drugs and their metabolites will be determined.

  3. Elimination rate constant (Ke) [ Time Frame: 72 hours ]
    Pharmacokinetic Parameter (h^−1) of the probe drugs and their metabolites will be determined.

  4. Elimination half life (t1/2) [ Time Frame: 72 hours ]
    Pharmacokinetic Parameter (h) of the probe drugs and their metabolites will be determined.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Caucasian
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482817


Locations
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Germany
Nuvisan GmbH
Neu-Ulm, Germany
Sponsors and Collaborators
Max Zeller Soehne AG
Investigators
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Principal Investigator: Michael Lissy Neu-Ulm

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Responsible Party: Max Zeller Soehne AG
ClinicalTrials.gov Identifier: NCT03482817    
Other Study ID Numbers: Ze117-1-2017-01
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No