QT Interval ProlongationNCT01653990
Moxifloxacin_QT Study in Chinese Healthy Volunteer
A study testing moxifloxacin in people with QT Interval Prolongation, run by Peking University Third Hospital at 1 site in China.
Trial summary
A single-center, randomized, double-blinded, 2-way crossover, placebo-controlled study to assess the QTc interval after administration of single oral dose of 400mg Moxifloxacin in healthy Chinese subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- QT Interval Prolongation
- What is being tested?
- moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to Oct 2012
- Phase
- Interventional
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Chinese subjects, male, 20 to 45 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- At Screening, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position after the subject has rested for 5 minutes. All of vital signs should be within normal ranges:
- Body temperature (Body) between 35.0-37.0°C
- 90 ≤ systolic blood pressure <140 mm Hg
- 60≤ diastolic blood pressure < 90 mm Hg
- 50≤ pulse rate ≤ 100
- Body weight need to be at least 50kg or above, 19kg/m2≤ Body Mass Index(BMI) ≤25kg/m2
- Be able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent prior to any screening procedures.
Who cannot join
- History or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, genetic or psychiatric disorders.
- A past medical history of clinically significant ECG abnormalities or a family history (grandparents, parents and siblings) of long QT syndrome, or QTc interval > 440 ms for male or any abnormal ECG findings at screening.
- Medical histories of syncope, electrophysiological changes, heart failure, reduced exercise tolerance, cardiomyopathy, pericarditis, myocarditis or other cardiac disorders as determined by the investigator.
- Current electrolyte abnormalities (specifically hypokalemia) in laboratory examination during the screening that are clinical significant as determined by investigator.
- Current or recent history (< 30 days prior to Screening) of a clinically significant illness.
- Use of any prescription drugs, herbal supplements, within 4 weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within 4 week prior to initial dosing.
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- Positive results of human immunodeficiency virus, Hepatitis B surface antigen or Hepatitis C antibody testing.
- History of any hypersensitivity or allergic reaction of moxifloxacin or other types fluoroquinolones.
- Use of tobacco or history of use of tobacco ( > 5 tobacco/week) or nicotine-containing products in the 3 months prior to screening.
- History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening and/or at baseline.
- Dosing of study drug in any clinical investigation within 3 months prior to initial dosing.
- Donation or loss of 200 ml or more of blood within 3 months prior to participation, or donation of component blood within 3 months prior to participation.
- Consumption of alcohol-, caffeine --containing foods or beverages within 48 hours preceding study drug administration.
- Other conditions which investigator deems potential harm to subjects if participate the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital Drug Clinical Trial Center
Beijing, 100191
Haiyan Li, MD, 861082266226, haianli1027@hotmail.com
Jingchuan Guo, MD
About this study
Official title: A Single-center, Randomized, Double-blinded, 2-way Crossover, Placebo-controlled Study to Assess the QT/QTc Interval After Administration of Single Oral Dose of 400mg Moxifloxacin in Healthy Chinese Subjects
A single-center, randomized, double-blinded, 2-way crossover, placebo-controlled study to assess the QTc interval after administration of single oral dose of 400mg Moxifloxacin in healthy Chinese subjects.
- Conditions
- QT Interval Prolongation
- Being tested
- moxifloxacin, moxifloxacin-placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moxifloxacinDrug
oral dose of 400mg moxifloxacin
moxifloxacin-placeboDrug
Oral dose of a pill of moxifloxacin-placebo
| Study group | Role | What they receive |
|---|---|---|
| moxifloxacin, pill | Experimental | Oral dose of 400mg moxifloxacin Receives: Drug: moxifloxacin; Drug: moxifloxacin-placebo |
| moxifloxacin-placebo,pill | Placebo comparator | A pill of moxifloxacin-placebo Receives: Drug: moxifloxacin; Drug: moxifloxacin-placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
baseline-adjusted, placebo-corrected effect on QTcF (ΔΔQTcF)
Measured: 1 month
Secondary outcomes (1)
Heart rate, PR, QRS, QTcB and QTcI
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for QT Interval ProlongationStudies of the same condition, open and under way.
- More trials run by Peking University Third 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haiyan Li, Peking University Third Hospital
- Investigators
- Haiyan Li, MD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653990
- Sponsor's protocol ID
- DCTC_2012001
- Status last verified
- Jul 2012
- First submitted
- 27 Jul 2012
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-blinded, 2-way Crossover, Placebo-controlled Study to Assess the QT/QTc Interval After Administration of Single Oral Dose of 400mg Moxifloxacin in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT01653990
- Acronym / sponsor ID
- DCTC_2012001
- Conditions
- QT Interval Prolongation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 31 Jul 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.
A single-center, randomized, double-blinded, 2-way crossover, placebo-controlled study to assess the QTc interval after administration of single oral dose of 400mg Moxifloxacin in healthy Chinese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| moxifloxacin, pill | Experimental | Drug: moxifloxacin, Drug: moxifloxacin-placeboOral dose of 400mg moxifloxacin |
| moxifloxacin-placebo,pill | Placebo comparator | Drug: moxifloxacin, Drug: moxifloxacin-placeboA pill of moxifloxacin-placebo |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy Chinese subjects, male, 20 to 45 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- At Screening, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position after the subject has rested for 5 minutes. All of vital signs should be within normal ranges:
- Body weight need to be at least 50kg or above, 19kg/m2≤ Body Mass Index(BMI) ≤25kg/m2
- Be able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent prior to any screening procedures.
Key exclusion criteria (14 listed)
- History or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, genetic or psychiatric disorders.
- A past medical history of clinically significant ECG abnormalities or a family history (grandparents, parents and siblings) of long QT syndrome, or QTc interval > 440 ms for male or any abnormal ECG findings at screening.
- Medical histories of syncope, electrophysiological changes, heart failure, reduced exercise tolerance, cardiomyopathy, pericarditis, myocarditis or other cardiac disorders as determined by the investigator.
- Current electrolyte abnormalities (specifically hypokalemia) in laboratory examination during the screening that are clinical significant as determined by investigator.
- Current or recent history (< 30 days prior to Screening) of a clinically significant illness.
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 |
|---|---|---|
| moxifloxacinoral dose of 400mg moxifloxacin | Drug | moxifloxacin, pill, moxifloxacin-placebo,pill |
| moxifloxacin-placeboOral dose of a pill of moxifloxacin-placebo | Drug | moxifloxacin, pill, moxifloxacin-placebo,pill |
Primary outcome
baseline-adjusted, placebo-corrected effect on QTcF (ΔΔQTcF)
Time frame: 1 month
1 secondary outcome
Heart rate, PR, QRS, QTcB and QTcI
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2012.
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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.
Haiyan Li, MD principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing moxifloxacin in people with QT Interval Prolongation, run by Peking University Third Hospital at 1 site in China.
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 8 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 31 Jul 2012. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jingchuan Guo, MD (861082265509, guojingchuan1029@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
baseline-adjusted, placebo-corrected effect on QTcF (ΔΔQTcF) (time frame: 1 month). 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 31 Jul 2012.