NCT01704638

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1 depression

Timeline
Completed

Started Aug 2008

Longer than P75 for phase_1 depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2012

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 11, 2012

Completed
Last Updated

September 1, 2015

Status Verified

August 1, 2015

Enrollment Period

4.2 years

First QC Date

September 21, 2012

Last Update Submit

August 31, 2015

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

2677TT

EXPERIMENTAL

Plasma kinetics of fluvoxamine and digoxin in this genotype

Drug: fluvoxamineDrug: Digoxin

2677GG

OTHER

plasma kinetics of fluvoxamine and digoxin in this genotype

Drug: fluvoxamineDrug: Digoxin

Interventions

fluvoxamineDRUG
2677GG2677TT
DigoxinDRUG
2677GG2677TT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CPTU

Stockholm, Sweden

Location

MeSH Terms

Conditions

Depression

Interventions

FluvoxamineDigoxin

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

OximesHydroxylaminesAminesOrganic ChemicalsDigitalis GlycosidesCardenolidesCardiac GlycosidesCardanolidesSteroidsFused-Ring CompoundsPolycyclic CompoundsGlycosidesCarbohydrates

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, specialist in clinical pharmacology

Study Record Dates

First Submitted

September 21, 2012

First Posted

October 11, 2012

Study Start

August 1, 2008

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

September 1, 2015

Record last verified: 2015-08

Locations

SE(1)