Kinetics of Fluvoxamine and Digoxin in Subjects With Different MDR1 Genotypes

Karolinska Institute

Status and phase: Completed; Phase 1

Conditions: Depression

Treatments: Drug: Digoxin; Drug: fluvoxamine

Study type: Interventional

Funder types: Other

Identifiers

NCT01704638

fluvoxaminedigoxin

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

2677TT

Experimental group

Description:

Plasma kinetics of fluvoxamine and digoxin in this genotype

Treatment:

Drug: Digoxin

Drug: fluvoxamine

2677GG

Other group

Description:

plasma kinetics of fluvoxamine and digoxin in this genotype

Treatment:

Drug: Digoxin

Drug: fluvoxamine