Drug Interaction Study
Conditions
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.
Interventions
DRUGZe 117
Subjects will be hospitalized to receive a probe drug cocktail alone and in combination with Ze 117.
Subjects will be hospitalized to receive a probe drug cocktail alone and in combination with Ze 117.
Sponsors
Max Zeller Soehne AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
open-label, non-randomized, single-sequence study
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Peak Plasma Concentration (Cmax) | 72 hours | Pharmacokinetic Parameter (ng/ml) of the probe drugs and their metabolites will be determined. |
| Elimination rate constant (Ke) | 72 hours | Pharmacokinetic Parameter (h\^-1) 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. |
Countries
Germany
Outcome results
None listed