Impact of CYP2C9 genotype and CYP2C9 inhibiting drugs in healthy volunteers Not Applicable
Conditions
Interventions
Participants are recruited based on their CYP2C9 genotype. This is blinded to the participant and the research team by a third party. The study is a crossover design, so participants will be treated w
Sponsors
University of Dundee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 - 60 years 2. Caucasian (to limit genetic variation as much as possible) 3. Not known to have diabetes 4. No daily treatment with antidiabetic medication, statins, amitriptyline or other drugs that inhibit or require CYP2C9 or CYP3A4 metabolism 5. No cognitive impairment or visual impairment 6. Known CYP2C9 genotype – either normal (“wild type”) or two reduced function alleles
Exclusion criteria
Exclusion criteria: 1. Heterozygous CYP2C9 genotype i.e. only one reduced function allele 2. Use of any antifungal drug within the last month 3. Recent involvement (<30 days) in a clinical trial 4. Pregnancy or planning to conceive 5. Inability/unwillingness to comply with the protocol 6. Anaemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Level of tolbutamide, and in the blood measured with UHPLC-MS/MS using blood samples taken at 0, 0.5, 1, 2, 3, 4, 6 hrs, derive pharmacokinetic parameters from measures (CL, T1/2, AUC) 2. Level of tolbutamide, 4-hydroxytolbutamide and carboxytolbutamide in the urine measured with UHPLC-MS/MS using urine samples collected from 0 to 12 hours and from 12 to 24 hours 3. Metabolomics (Metabolon, MS/MS) will measured on T=0 hr samples | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactMads;Ewan Kjolby;Pearson
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Outcome results
None listed