Kinetics of Fluvoxamine and Digoxin in Subjects With Different MDR1 Genotypes

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CPTU

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluvoxamine

Drug

Digoxin

Drug

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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Important dates

Study start: 2008
Primary completion: 2012
Study completion: 2012
First posted: Oct 11, 2012
Registry last updated: Sep 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed