DepressionPhase 1NCT01704638
Kinetics of Fluvoxamine and Digoxin in Subjects With Different MDR1 Genotypes
A Phase 1 study testing fluvoxamine and Digoxin in people with Depression, run by Karolinska Institutet at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- fluvoxamine and Digoxin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2008to Oct 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- - 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
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Depression
- Being tested
- fluvoxamine, Digoxin
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluvoxamineDrug
DigoxinDrug
| Study group | Role | What they receive |
|---|---|---|
| 2677TT | Experimental | Plasma kinetics of fluvoxamine and digoxin in this genotype Receives: Drug: fluvoxamine; Drug: Digoxin |
| 2677GG | Other | plasma kinetics of fluvoxamine and digoxin in this genotype Receives: Drug: fluvoxamine; Drug: Digoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startAug 2008
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Sparve, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704638
- Sponsor's protocol ID
- fluvoxaminedigoxin
- Status last verified
- Aug 2015
- First submitted
- 21 Sep 2012
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinetics of Fluvoxamine and Digoxin in Subjects With Different MDR1 Genotypes
- ClinicalTrials.gov ID
- NCT01704638
- Acronym / sponsor ID
- fluvoxaminedigoxin
- Conditions
- Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 11 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2677TT | Experimental | Drug: fluvoxamine, Drug: DigoxinPlasma kinetics of fluvoxamine and digoxin in this genotype |
| 2677GG | Other | Drug: fluvoxamine, Drug: Digoxinplasma kinetics of fluvoxamine and digoxin in this genotype |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- - 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
Key exclusion criteria (4 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluvoxamine | Drug | 2677GG, 2677TT |
| Digoxin | Drug | 2677GG, 2677TT |
Primary outcome
Cmax of fluvoxamine and of digoxin
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing fluvoxamine and Digoxin in people with Depression, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of fluvoxamine and of digoxin (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2015.