Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT05463003
Eligibility Criteria:
Inclusion Criteria:
* any sex
* OCT1 wildtype: homozygous for OCT\*1
* OCT "poor transporter": homozygous or heterozygous for OCT1\*3, \*4, \*5, \*6
* CYP2D6 wildtype: homozygous or heterozygous for \*1, \*2, \*35
* CYP2D6 "poor metabolizer": homozygous or heterozygous for \*3, \*4, \*5, \*6
* age between 18 and 50 years
* understands the study purpose and design
* contractually capable and provides signed informed consent form
* healthy condition or mild and/or well treated forms of allergies, asthma, hypertension, and orthopedic diseases
* a maximum of 3 chronically taken drugs not interfering with OCT1 and CYP2D6 activities
Exclusion Criteria:
* BMI \> 35 kg/m2 and \<18 kg/m2
* known pregnancy or lactation period
* women: positive urine pregnancy test at screening or pharmacokinetic visit
* anemia (hemoglobin \< 13 g/dl (8,07 mmol/l) in men or \< 12 g/dl (7,45 mmol/l) in women
* elevated liver function tests (\> 2x ULN)
* reduced renal function (eGFRMDRD \< 60 ml/min/1,7m2)
* psychiatric disease or drug dependency at time of visit
* use of recreational drugs more than twice a week
* poor venous conditions that make it impossible to place a peripheral venous catheter and regularly draw blood through it
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT05463003
Study Brief:
Protocol Section:
NCT05463003