Kinetics of Fluvoxamine and Digoxin in Subjects With Different MDR1 Genotypes
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Cmax of fluvoxamine and of digoxin
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
2677GG
plasma kinetics of fluvoxamine and digoxin in this genotype
Intervention: fluvoxamine (Drug)
2677GG
plasma kinetics of fluvoxamine and digoxin in this genotype
Intervention: Digoxin (Drug)
2677TT
Plasma kinetics of fluvoxamine and digoxin in this genotype
Intervention: fluvoxamine (Drug)
2677TT
Plasma kinetics of fluvoxamine and digoxin in this genotype
Intervention: Digoxin (Drug)
Outcomes
Primary Outcomes
Cmax of fluvoxamine and of digoxin
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Erik Sparve
MD, specialist in clinical pharmacology
Karolinska Institutet