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NCT07817030

Evaluation of Solanidine as an Exogenous Biomarker to Phenotype CYP2D6 Activity in Humans

Sponsor: University Medicine Greifswald

View on ClinicalTrials.gov

Summary

This study investigates the evaluation of solanidine as an exogenous biomarker to phenotype CYP2D6-activity in humans. Participants will be classified by their CYP2D6 genotype into poor metabolizers (PM), low intermediate metabolizers (LIM), extensive metabolizers (EM) and ultra-rapid metabolizers (UM), forming four distinct study arms: Arm 1) Poor Metabolizers (PM) n=10 Arm 2) Low Intermediate Metabolizers (LIM) n=5 Arm 3) Extensive Metabolizers (EM) n=10 Arm 4) Ultra-rapid Metabolizers (UM) n=5 Participants will be given a standardized potato-rich meal, serving as the natural source of solanidine, and will be phenotyped for CYP2D6 activity with a single oral microdose of the probe drug yohimbine. The objectives of the study are as follows: 1. To evaluate the suitability of the SSDA/solanidine and m414/solanidine metabolic ratio as an exogenous biomarker to phenotype CYP2D6 activity in humans. 2. To characterize the postprandial plasma concentration profile of solanidine, its CYP2D6-dependent metabolites, and its parent molecules α-solanine and α-chaconine following a potato-rich meal.

Key Details

Gender

All

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-09-21

Completion Date

2027-12-31

Last Updated

2026-09-14

Healthy Volunteers

Yes

Conditions

Pharmacokinetic Study in Healthy Volunteers

Interventions

DIETARY_SUPPLEMENT

Yohimbine

A single oral dose of 50 µg yohimbine, administered as 2 x 1 tablets of Yohimbinum hydrochloricum D4® will be administered as drinking solution with 240mL of water under overnight fasting conditions. A total of 6 blood samples will be collected at defined time points (baseline; 10; 20; 30; 60; 120 min). At each time point, 5 mL of blood will be drawn for plasma separation to determine yohimbine and the primary metabolite 11-OH-yohimbine.

OTHER

Consumption of a defined potato-rich meal

Potato Intervention (2 phases): Diet restriction: No potato products 3 days before and until 60h after each meal. Ad libitum food intake is allowed from 6h post-meal. Blood will be analyzed for solanidine, its metabolites and its parent molecules α-solanine, and α-chaconine. Phase 1 (0-12h postprandial): Baseline blood draw at 8:00 AM, followed by supervised ingestion of a potato-rich meal. A total of 7 blood samples will be collected (baseline, 2, 4, 6, 8, 10, 12h) before discharge from the CRU. Phase 2 (12-60h postprandial): Baseline blood draw at 7:30 PM, identical meal ingestion at 8:00 PM. Participants can go home afterwards and return to the CRU the next morning at 8:00 AM for their 12 hour post meal blood draw. A total of 10 blood samples will be collected (baseline, 12, 14, 16, 18, 20, 22, 24h, 36h next morning, 60h subsequent morning).

Inclusion Criteria: 1. individuals of both biological sexes, assigned as women or men at birth 2. age: ≥ 18 and ≤ 40 years 3. possesses the ability to understand the study purpose and design 4. contractually capable and provides signed informed consent form 5. in good general health or with mild and/or well-managed conditions such as allergies, asthma, hypertension or orthopedic diseases 6. taking no more than three chronic medications 7. ability to maintain and record a detailed dietary protocol focusing on the consumption of potato-based products for the specified duration of the study 8. individuals classified as either ultrarapid metabolizers (UM), extensive metabolizers (EM), low intermediate metabolizers (LIM) or poor metabolizers (PM) based on their CYP2D6 genotype: Poor Metabolizer (PM, Gen-Score 0): homozygous or compound heterozygous for CYP2D6 \*3, CYP2D6 \*4, CYP2D6\*5, CYP2D6 \*6 Low Intermediate Metabolizer (LIM, Gen-Score 0,25 or 0,5): Homozygous or compound heterozygous for CYP2D6 \*9, \*10, \*41 or compound heterozygous with one allele of CYP2D6 \*3, CYP2D6 \*4, CYP2D6\*5, or CYP2D6\*6 and one allele of CYP2D6 \*17 (0,5) or CYP2D6 \*9, \*10, or \*41 (0,25) Extensive Metabolizer (EM, Gene-Score 2): homozygous or compound heterozygous for CYP2D6 \*1, CYP2D6 \*2, CYP2D6\*35 Ultrarapid Metabolizer (UM, Gen-Score ≥ 3): homozygous or compound heterozygous for CYP2D6 \*1, CYP2D6 \*2, CYP2D6\*35 with at least one allele duplicated or multiplied Exclusion Criteria: 1. BMI \> 30 kg/m2 and \< 18 kg/m2 2. body weight \< 48 kg 3. women: known pregnancy or lactation period; positive urine pregnancy test at screening or kinetic visit 4. men: hemoglobin \< 13 g/dl (8,07 mmol/l) women: hemoglobin \< 12 g/dl (7,45 mmol/l) 5. elevated liver function tests (1 or more of ALAT, ASAT, yGT, Bilirubin \> 2x ULN) 6. reduced renal function (eGFRMDRD \< 60 mL/min/1,7 m2) 7. QTcF \> 450 ms in screening ECG 8. current or recent psychiatric disorders requiring treatment including depression, bipolar disorder, schizophrenia, psychosis or severe anxiety disorders 9. drug dependency at the time of visit 10. use of recreational drugs more than twice a week 11. intake of drugs interfering with CYP2D6 during the past seven days 12. any known hypersensitivity or allergic reactions to yohimbine 13. intake of yohimbine within 48 hours prior to study participation 14. history of hypersensitivity or allergy to potatoes or nightshade vegetables 15. intake of potato-containing meals during the three days before and after eating the potato-rich test meal 16. history of severe hypersensitivity reactions and/or anaphylaxis 17. poor venous conditions that make it impossible to place a peripheral venous catheter and regularly draw blood through it 18. engagement in extreme physical activity within 48 hours prior to study participation

Locations (1)

University Medicine Greifswald

Greifswald, Mecklenburg-Vorpommern, Germany