HealthyPhase 1NCT01871701
Clinical Trial to Investigate the Effect on Corrected QT Interval Prolongation by Psychotropic Drugs
A Phase 1 study testing Escitalopram, Quetiapine and Moxifloxacin in people with Healthy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To evaluate the corrected QT interval change(automatic-reading) after single oral administration of escitalopram, quetiapine and moxifloxacin versus placebo in healthy Korean Adults. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Escitalopram, Quetiapine and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2012to May 2014
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects aged 20 - 40 years.
- A body weight in the range of 50 kg (inclusive) - 90 kg (inclusive) and a body mass index (BMI) in the range 19.0 kg/m2 (inclusive) - 25.0 kg/m2 (inclusive).
- Sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully. informed about the study procedures.
Who cannot join
- Presence or history of hypersensitivity or allergic reactions to drugs including investigational product (Escitalopram, Quetiapine, Moxifloxacin)) or other quinolone group antibiotics.
- Subject judged not eligible for study participation by investigator.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam, Gyounggi
About this study
Official title: Clinical Trial to Investigate the Effect on Corrected QT Interval Prolongation by Psychotropic Drugs in Healthy Korean Adults After a Single Oral Administration of Escitalopram, Quetiapine, and Moxifloxacin
To evaluate the corrected QT interval change(automatic-reading) after single oral administration of escitalopram, quetiapine and moxifloxacin versus placebo in healthy Korean Adults.
Read the detailed description
Randomized, Open-label, Placebo-controlled, 4-way crossover study
- Conditions
- Healthy
- Being tested
- Escitalopram, Quetiapine, Moxifloxacin, Placebo
- Keywords
- Corrected QT interval prolongation, Psychotropic drugs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Also called Escitalopram 20 mg (Lexapro, Tablet)
Escitalopram
QuetiapineDrug
Also called Quetiapine 100 mg (Seroquel, Tablet)
Quetiapine
MoxifloxacinDrug
Also called Moxifloxacin 400 mg (Avelox, Tablet)
Moxifloxacin
PlaceboOther
Also called Water intake
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Quetiapine | Experimental | Quetiapine 100 mg (Seroquel, Tablet) Receives: Drug: Quetiapine |
| Moxifloxacin | Experimental | Moxifloxacin 400 mg (Avelox, Tablet) Receives: Drug: Moxifloxacin |
| Escitalopram | Experimental | Escitalopram 20 mg (Lexapro, Tablet) Receives: Drug: Escitalopram |
| Placebo | Placebo comparator | Water intake Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corrected QT interval prolongation
Measured: Predose (3 times) and 1, 2, 3, 4, 6, 8, 12, 16, 24 h, additional 26, 28, 32, 48 h after escitalopram dosing
Secondary outcomes (2)
AUC (area under the plasma concentration-time curve) of escitalopram
AUC, Cmax, Tmax, t1/2, CL/F
Measured: Predose and 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48h postdose
AUC (area under the plasma concentration-time curve)of quetiapine, moxifloxacin
AUC, Cmax, Tmax, t1/2, CL/F
Measured: Predose and 1, 2, 3, 4, 6, 8, 12, 16, 24 h postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startNov 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Responsible party
- Principal investigator, Jae Yong Chung, Seoul National University Bundang Hospital
- Investigators
- Jae-Yong Chung, MD, PhD, Principal investigator, Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seongnam, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01871701
- Sponsor's protocol ID
- CNSQT
- Status last verified
- May 2014
- First submitted
- 5 Dec 2012
- Last updated
- 3 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Investigate the Effect on Corrected QT Interval Prolongation by Psychotropic Drugs in Healthy Korean Adults After a Single Oral Administration of Escitalopram, Quetiapine, and Moxifloxacin
- ClinicalTrials.gov ID
- NCT01871701
- Acronym / sponsor ID
- CNSQT
- Conditions
- Healthy
- Keywords
- Corrected QT interval prolongation, Psychotropic drugs
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Study start
- Nov 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 7 Jun 2013 (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.
To evaluate the corrected QT interval change(automatic-reading) after single oral administration of escitalopram, quetiapine and moxifloxacin versus placebo in healthy Korean Adults.
Detailed description
Randomized, Open-label, Placebo-controlled, 4-way crossover study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Quetiapine | Experimental | Drug: QuetiapineQuetiapine 100 mg (Seroquel, Tablet) |
| Moxifloxacin | Experimental | Drug: MoxifloxacinMoxifloxacin 400 mg (Avelox, Tablet) |
| Escitalopram | Experimental | Drug: EscitalopramEscitalopram 20 mg (Lexapro, Tablet) |
| Placebo | Placebo comparator | Other: PlaceboWater intake |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy subjects aged 20 - 40 years.
- A body weight in the range of 50 kg (inclusive) - 90 kg (inclusive) and a body mass index (BMI) in the range 19.0 kg/m2 (inclusive) - 25.0 kg/m2 (inclusive).
- Sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully. informed about the study procedures.
Key exclusion criteria (2 listed)
- Presence or history of hypersensitivity or allergic reactions to drugs including investigational product (Escitalopram, Quetiapine, Moxifloxacin)) or other quinolone group antibiotics.
- Subject judged not eligible for study participation by investigator.
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 |
|---|---|---|
| EscitalopramAlso: Escitalopram 20 mg (Lexapro, Tablet)Escitalopram | Drug | Escitalopram |
| QuetiapineAlso: Quetiapine 100 mg (Seroquel, Tablet)Quetiapine | Drug | Quetiapine |
| MoxifloxacinAlso: Moxifloxacin 400 mg (Avelox, Tablet)Moxifloxacin | Drug | Moxifloxacin |
| PlaceboAlso: Water intakePlacebo | Other | Placebo |
Primary outcome
Corrected QT interval prolongation
Time frame: Predose (3 times) and 1, 2, 3, 4, 6, 8, 12, 16, 24 h, additional 26, 28, 32, 48 h after escitalopram dosing
2 secondary outcomes
AUC (area under the plasma concentration-time curve) of escitalopram
Time frame: Predose and 1, 2, 3, 4, 6, 8, 12, 16, 24, 30, 36, 48h postdose
AUC (area under the plasma concentration-time curve)of quetiapine, moxifloxacin
Time frame: Predose and 1, 2, 3, 4, 6, 8, 12, 16, 24 h postdose
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 3 Jun 2014.
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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.
Jae-Yong Chung, MD, PhD principal investigator
Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seongnam, Korea
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 Escitalopram, Quetiapine and Moxifloxacin in people with Healthy, run by Seoul National University Hospital at 1 site in South Korea.
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 3 inclusion and 2 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 3 Jun 2014. 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
Corrected QT interval prolongation (time frame: Predose (3 times) and 1, 2, 3, 4, 6, 8, 12, 16, 24 h, additional 26, 28, 32, 48 h after escitalopram dosing). 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 3 Jun 2014.