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Kinetics of Fluvoxamine and Digoxin in Subjects With Different MDR1 Genotypes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 21, 2012
First Posted Date  ICMJE October 11, 2012
Last Update Posted Date September 1, 2015
Study Start Date  ICMJE August 2008
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01704638 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Kinetics of Fluvoxamine and Digoxin in Subjects With Different MDR1 Genotypes
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Depression
Intervention  ICMJE
  • Drug: fluvoxamine
  • Drug: Digoxin
Study Arms  ICMJE
  • Experimental: 2677TT
    Plasma kinetics of fluvoxamine and digoxin in this genotype
    Interventions:
    • Drug: fluvoxamine
    • Drug: Digoxin
  • 2677GG
    plasma kinetics of fluvoxamine and digoxin in this genotype
    Interventions:
    • Drug: fluvoxamine
    • Drug: Digoxin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 31, 2015)
14
Original Estimated Enrollment  ICMJE
 (submitted: October 10, 2012)
16
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01704638
Other Study ID Numbers  ICMJE fluvoxaminedigoxin
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Erik Sparve, Karolinska Institutet
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Karolinska Institutet
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP