Kinetics of Fluvoxamine and Digoxin in Subjects With Different MDR1 Genotypes

Depression Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01704638
• Other study ID #: fluvoxaminedigoxin
• Status: Completed
• Phase: Phase 1
• First received: September 21, 2012
• Last updated: August 31, 2015
• Start date: August 2008
• Est. completion date: October 2012

Study information

• Verified date: August 2015
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: has been evaluated as not needing oversight from Medical Products Agency by them.
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Depression

Intervention

Drug:
• fluvoxamine

• Digoxin

Locations

Country	Name	City	State
Sweden	CPTU	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	No