Kinetics of Fluvoxamine and Digoxin in Subjects With Different MDR1 Genotypes

Phase 1

Completed

• Conditions: Depression
• Interventions: Drug: fluvoxamine; Drug: Digoxin

• Registration Number: NCT01704638
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2012-09-21
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Study First Submitted QC: 2012-10-10
• Study First Posted: 2012-10-11
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-31
• Last Update Posted: 2015-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2677TT	fluvoxamine	Plasma kinetics of fluvoxamine and digoxin in this genotype
2677GG	Digoxin	plasma kinetics of fluvoxamine and digoxin in this genotype
2677TT	Digoxin	Plasma kinetics of fluvoxamine and digoxin in this genotype
2677GG	fluvoxamine	plasma kinetics of fluvoxamine and digoxin in this genotype

Primary Outcome Measures

Name	Time	Method
Cmax of fluvoxamine and of digoxin	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.

Trial Locations

Locations (1)

CPTU; 🇸🇪 Stockholm, Sweden