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Kinetics of Fluvoxamine and Digoxin in Subjects With Different MDR1 Genotypes

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ClinicalTrials.gov Identifier: NCT01704638
Recruitment Status : Completed
First Posted : October 11, 2012
Last Update Posted : September 1, 2015
Sponsor:
Information provided by (Responsible Party):
Erik Sparve, Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
Depression Drug: fluvoxamine Drug: Digoxin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : August 2008
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012


Arm Intervention/treatment
Experimental: 2677TT
Plasma kinetics of fluvoxamine and digoxin in this genotype
Drug: fluvoxamine
Drug: Digoxin
2677GG
plasma kinetics of fluvoxamine and digoxin in this genotype
Drug: fluvoxamine
Drug: Digoxin



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704638


Locations
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Sweden
CPTU
Stockholm, Sweden
Sponsors and Collaborators
Karolinska Institutet

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Responsible Party: Erik Sparve, MD, specialist in clinical pharmacology, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01704638     History of Changes
Other Study ID Numbers: fluvoxaminedigoxin
First Posted: October 11, 2012    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms
Digoxin
Fluvoxamine
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors