Status:
RECRUITING
Kinetics of Yohimbine in Humans to Explore Sex and CYP2D6 Genotype Interactions
Lead Sponsor:
University Medicine Greifswald
Conditions:
Pharmacokinetic Study in Healthy Volunteers
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
This study investigates the pharmacokinetics of yohimbine in women and men aged 18 to 40 years to explore sex-specific differences in CYP2D6-dependent drug metabolism. Participants will be classified ...
Detailed Description
The study is designed as an open-label, single-dose protocol with four study arms based on sex and CYP2D6 genotype. A single oral dose of yohimbine and ¹³C₃-caffeine will be administered with 240 ml o...
Eligibility Criteria
Inclusion
- individuals of both biological sexes, assigned as women or men at birth
- age: ≥ 18 and ≤ 40 years
- possesses the ability to understand the study purpose and design
- contractually capable and provides signed informed consent form
- in good general health or with mild and/or well-managed conditions such as allergies, asthma, hypertension or orthopedic diseases
- taking no more than three chronic medications
- individuals classified as either extensive metabolizers (EM) or poor metabolizers (PM) based on their CYP2D6 genotype:
- Extensive Metabolizers (EM):
- homozygous for CYP2D6 \*1,CYP2D6 \*2, CYP2D6 \*35, or heterozygous combination of any of these alleles
- Poor Metabolizers (PM):
- homozygous for CYP2D6 \*3, CYP2D6 \*4, CYP2D6 \*5, CYP2D6 \*6, or heterozygous combination of any of these alleles
Exclusion
- BMI \> 30 kg/m2 and \< 18 kg/m2
- body weight \< 48 kg
- women: known pregnancy or lactation period; positive urine pregnancy test at screening or kinetic visit
- men: hemoglobin \< 13 g/dl (8,07 mmol/l) women: hemoglobin \< 12 g/dl (7,45 mmol/l)
- elevated liver function tests (1 or more of ALAT, ASAT, yGT, Bilirubin \> 2x ULN)
- reduced renal function (eGFRMDRD \< 60 mL/min/1,7 m2)
- QTcF \> 450 ms in screening ECG
- current or recent psychiatric disorders requiring treatment including depression, bipolar disorder, schizophrenia, psychosis or severe anxiety disorders
- drug dependency at the time of visit
- use of recreational drugs more than twice a week
- any known hypersensitivity or allergic reactions to yohimbine or caffeine
- history of severe hypersensitivity reactions and/or anaphylaxis
- poor venous conditions that make it impossible to place a peripheral venous catheter and regularly draw blood through it
- o) intake of drugs interfering with CYP2D6 and/or CYP1A2 during the past seven days p) intake of yohimbine within 48 hours and caffeine within 16 hours prior to study participation q) engagement in extreme physical activity within 48 hours prior to study participation
Key Trial Info
Start Date :
April 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06939608
Start Date
April 28 2025
End Date
September 30 2025
Last Update
April 29 2025
Active Locations (1)
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1
University Medicine Greifswald, Institute of Pharmacology
Greifswald, Mecklenburg-Vorpommern, Germany, 17489