Kinetics of Fluvoxamine and Digoxin in Subjects With Different MDR1 Genotypes

NCT ID: NCT01704638

Last Updated: 2015-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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2677TT

Plasma kinetics of fluvoxamine and digoxin in this genotype

Group Type EXPERIMENTAL

fluvoxamine

Intervention Type DRUG

Digoxin

Intervention Type DRUG

2677GG

plasma kinetics of fluvoxamine and digoxin in this genotype

Group Type OTHER

fluvoxamine

Intervention Type DRUG

Digoxin

Intervention Type DRUG

Interventions

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fluvoxamine

Intervention Type DRUG

Digoxin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Erik Sparve

MD, specialist in clinical pharmacology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CPTU

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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fluvoxaminedigoxin

Identifier Type: -

Identifier Source: org_study_id

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