Back to resultsKinetics of Fluvoxamine and Digoxin in Subjects With Different MDR1 Genotypes
Primary Purpose
Depression
Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
fluvoxamine
Digoxin
Sponsored by
About this trial
This is an interventional basic science trial for Depression
Eligibility 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
Sites / Locations
- CPTU
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
2677TT
2677GG
Arm Description
Plasma kinetics of fluvoxamine and digoxin in this genotype
plasma kinetics of fluvoxamine and digoxin in this genotype
Outcomes
Primary Outcome Measures
Cmax of fluvoxamine and of digoxin
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01704638
First Posted
September 21, 2012
Last Updated
August 31, 2015
Sponsor
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT01704638
Brief Title
Kinetics of Fluvoxamine and Digoxin in Subjects With Different MDR1 Genotypes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2677TT
Arm Type
Experimental
Arm Description
Plasma kinetics of fluvoxamine and digoxin in this genotype
Arm Title
2677GG
Arm Type
Other
Arm Description
plasma kinetics of fluvoxamine and digoxin in this genotype
Intervention Type
Drug
Intervention Name(s)
fluvoxamine
Intervention Type
Drug
Intervention Name(s)
Digoxin
Primary Outcome Measure Information:
Title
Cmax of fluvoxamine and of digoxin
Description
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.
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
CPTU
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Kinetics of Fluvoxamine and Digoxin in Subjects With Different MDR1 Genotypes
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