Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003546-33 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the effect of the organic cation transporter OCT1 polymorphisms on the pharmacokinetics of several drugs in order to explain efficacy and adverse effects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug application | Experimental | 6 treatment periods. On each period one of the following interventions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug application Amitriptyline | Drug | Amitriptyline: 25 mg, single oral application |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve (AUC) of the investigational drugs | up to 60 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total clearance, Cmax, Tmax, Mean AbsorptionTime, Alpha and Beta half-lives, Mean Residence Time (MRT) and Volume of distribution of the investigated drugs and their metabolites | up to 60 hours | |
| Dry mouth, fatigue, nausea, headache, vertigo, tinnitus, chills, anxiety and difficulties to read on Visual Analog Scales. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Juergen Brockmoeller, Prof. | University Medical Center Goettingen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Pharmacology, University Medical Center Goettingen | Göttingen | 37075 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28791698 | Derived | Tzvetkov MV, Matthaei J, Pojar S, Faltraco F, Vogler S, Prukop T, Seitz T, Brockmoller J. Increased Systemic Exposure and Stronger Cardiovascular and Metabolic Adverse Reactions to Fenoterol in Individuals with Heritable OCT1 Deficiency. Clin Pharmacol Ther. 2018 May;103(5):868-878. doi: 10.1002/cpt.812. Epub 2017 Dec 8. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug application Desvenlafaxine |
| Drug |
Desvenlafaxine: 50 mg, single oral application |
|
| Drug application Sumatriptan | Drug | Sumatriptan: 50 mg, single oral application |
|
| Drug application Proguanil | Drug | Proguanil: 200mg, single oral application |
|
| Drug application Fenoterol | Drug | Fenoterol: 180 mcg, single intravenous application |
|
| Drug application Thiamine | Drug | Thiamine: 200mg, single oral application |
|
| up to 60 hours |
| Sedation on Stanford sedation scale | up to 60 hours |
| Pupil diameter, latency, diameter at maximal constriction, amplitude and time for 33% recovery of initial pupil diameter measured by pupillometrie | up to 60 hours |
| Genetic variants in OCT1, CYP2C19, CYP2D6 and MAO A | Baseline |