Depression
Conditions
Brief summary
The investigators will compare plasma kinetics of two marker drugs in individuals with different genetic variations in the MDR1-gene. The hypothesis is that one group will have higher exposure than the other.
Interventions
DRUGfluvoxamine
DRUGDigoxin
Sponsors
Karolinska Institutet
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* \- Healthy volunteer ≥ 18 years of age * Normal kidney function as measured by GFR according to Cockroft-Gault (70-120 ml/min) * Normal P-potassiumvalue (3,6-4,6 mmol/L) * HF\>50 and no AV-block on resting ECG. No other significant abnormalities as judged by the investigator. * Subject giving written informed consent * Subject capable of understanding instructions
Exclusion criteria
* \- Pregnancy * Ongoing infection * Intake of medication, including natural remedies (for example St John´s wort), within one month prior to starting study except for paracetamol. * Active drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of fluvoxamine and of digoxin | 2 days for fluvoxamine and 2 days for digoxin. Washout period of at least 1 week between the both parts. Total study time maximum 4 weeks. | The participants are administered a single dose of fluvoxamine or digoxin. Plasma kinetics of fluvoxamine are followed for 36 hours. Plasma kinetics of digoxin are followed for 48 hours. There is a washout period between the both parts. |
Countries
Sweden
Outcome results
None listed