Kinetics of Fluvoxamine and Digoxin in Subjects With Different MDR1 Genotypes | NCT01704638 | Trialant
CompletedInterventionalPhase 1Updated Sep 1, 2015
Kinetics of Fluvoxamine and Digoxin in Subjects With Different MDR1 Genotypes
ClinicalTrials.gov ID
NCT01704638
Lead Sponsor
Karolinska InstitutetOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1
Enrollment
14Actual
Last Update Posted
Sep 1, 2015Estimated
Start Date
Aug 2008
Primary Completion Date
Oct 2012Actual
Completion Date
Oct 2012Actual
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.
Depression
fluvoxamine
Digoxin
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
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.