- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03362853
A Study Evaluating the Effect of a Single-dose Oral Administration of Nemonoxacin Capsule on QTc Intervals and Heart Rhythms of Healthy Subjects and the Influence of Food Intake on QTc Intervals and Pharmacokinetic Characteristics
December 4, 2017 updated by: TaiGen Biotechnology Co., Ltd.
A Randomized, Single-center, Placebo and Positive Control, 4-period and 4-crossover Clinical Study Evaluating the Effect of a Single-dose Oral Administration of Nemonoxacin Malate Capsule on QTc Intervals and Heart Rhythms of Healthy Subjects as Well as the Influence of Food Intake on QTc Intervals and Pharmacokinetic Characteristics
A randomized, single-center, placebo and positive control, 4-period and 4-crossover clinical study with the following main purposes: (1) To evaluate the effect of a single-dose oral administration of nemonoxacin malate capsule on QTc intervals and heart rhythms of healthy subjects.
(2) To evaluate the influence of food intake on QTc intervals and pharmacokinetic characteristics.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female, aged between 18 and 40 during the screening period.
- A volunteer's Body Mass Index (BMI) had to be between 19~24 kg/m2, and a male volunteer's body weight was no less than 50 kg, while female, no less than 45 kg.
- A subject was judged as a healthy one by investigators according to his/her medical history, physical examination, 12-lead ECG examination, and laboratory test results.
A female subject:
- was post-menopausal for at least 1 year, or
- had been surgically sterilized, or
- met the following conditions if she was fertile: (i)her urine pregnancy test results were negative before she started the trial, and (ii)she agreed to use an approved birth control method (e.g. oral contraceptive, spermicide, condom, or intrauterine contraceptive device) throughout the study, and agreed to continue using birth control method within 1 month after the study, and (iii)she may not breastfeed.
- A male subject had to use a reliable birth control method (using a condom, or his partner executed the foresaid criteria) throughout the study and within 1 month after the study.
- A subject had never used tobacco or nicotine products within 1 month before receiving the study drug.
- A subject had never drunk alcohol or drunk more than 12 times within 3 months before receiving the study drug.
- A subject was willing to completely abstain from foods or beverages containing caffeine or xanthine such as coffee, tea, chocolate, alcohol, grapefruit juice, orange juice, etc within 24 hours before receiving the study drug and during his/her Stage I ward stay.
- A subject was willing to sign the Informed Consent Form.
Exclusion Criteria:
- had any personal or family history of sudden cardiac death, myocardial ischemia, myocardial infarction, congestive heart failure, long QT syndrome, hypokalemia, myocarditis, exertional dyspnea, cerebrovascular accident, venous thromboembolism, etc; or
- needed to use medicine to treat QTc interval prolongation (e.g. Category I or III antiarrhythmic drugs, please refer to Appendix 1) or medicine to treat heart disease; or
- was found to have abnormal mean values of parameters in 12-lead ECG during the screening: PR >240 ms, QRS >110 ms, male QTcF >430 ms (the automated machine-derived QTcF results in Lead II ECG were used and needed to be confirmed by the investigators), female QTcF >450 ms (the automated machine-derived QTcF results in Lead II ECG were used and needed to be confirmed by the investigators), bradycardia (heart rate <50 bpm); or
- had clinical abnormalities in 12-lead ECG during screening (e.g. atrioventricular block, torsades de pointes (TdP), other types of ventricular tachycardia, ventricular fibrillation and ventricular flutter, clinically significant T wave changes, or any 12-lead ECG abnormalities that may influence QTc intervals); or
- had systolic blood pressure >140 mmHg or <90 mmHg, diastolic blood pressure >90 mmHg, pulse <50 bpm or >100 bpm during the screening; or
- had a positive result in hepatitis B virus or hepatitis C virus serology test; or
- had a positive pregnancy test result or was currently in lactation period; or
- was found to have any laboratory test value that was outside the reference value (normal value±10%) during the screening, and that was deemed to have clinical significance by investigators; or
- had a history of diabetes or cardiovascular disease, liver disease or kidney disease; or
- had malabsorption syndrome or any other gastrointestinal disease that may influence drug absorption; or
- had any history of epileptic seizures, or mental disease that may affect protocol compliance, or had a suicidal risk, or had history of alcohol or prohibited drug abuse; or
- had any disease known to severely affect the immune system, e.g. history of human immunodeficiency virus (HIV) infection, hematologic or solid organ malignancy, or had a splenectomy, etc; or
- had a hypersensitive idiosyncrasy or hypersensitivity to any drugs, including quinolones or fluoroquinolones; or
- had a surgery or trauma history within 6 months before receiving the study drug; or
- had, as shown from his/her medical history, used any known liver enzyme inducer or liver enzyme inhibitor such as benzedrine, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates, phencyclidine, etc within 30 days before receiving the study drug; or
- had used any other trial drugs within 30 days before receiving the study drug; or
- had used any prescription drugs or Chinese herbal medicines within 14 days before receiving the study drug; or
- had used any OTC drugs or nutrition supplements (including the products containing multivalent cation such as calcium, aluminum, magnesium, iron, and zinc, as well as sucralfate, antacids, nutrition supplements, vitamin complex, and dietary metal supplements, etc) within 7 days before receiving the study drug; or
- had donated ≥400 ml of blood within 3 months before drug administration; or
- had, as judged by the investigators, any past or current disease or physical condition that may affect the safety or effect evaluation of the study drug; or
- was identified by the investigators as unsuitable to participate in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo oral capsule
|
Receive a single dose in a fasting state
Other Names:
Receive a single dose in a fasting state
Receive a single dose in a fasting state
Other Names:
Receive a single dose in a fasting state
|
EXPERIMENTAL: Nemonoxacin 500Mg Capsule
|
Receive a single dose in a fasting state
Other Names:
Receive a single dose in a fasting state
Receive a single dose in a fasting state
Other Names:
Receive a single dose in a fasting state
|
EXPERIMENTAL: Nemonoxacin 750Mg Capsule
|
Receive a single dose in a fasting state
Other Names:
Receive a single dose in a fasting state
Receive a single dose in a fasting state
Other Names:
Receive a single dose in a fasting state
|
ACTIVE_COMPARATOR: Moxifloxacin 400Mg Tablet
|
Receive a single dose in a fasting state
Other Names:
Receive a single dose in a fasting state
Receive a single dose in a fasting state
Other Names:
Receive a single dose in a fasting state
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ECG analysis - baseline-adjusted mean QTcF
Time Frame: 2 days
|
To compare the post-dosing placebo-corrected, baseline-adjusted mean QTcF differences (ΔΔQTcF) of nemonoxacin 500 mg/750 mg groups and placebo group at corresponding time points with the manually measured QTcF in Lead II of ECG.
|
2 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ECG analysis - baseline-adjusted mean QTcB
Time Frame: 2 days
|
To compare the post-dosing placebo-corrected, baseline-adjusted mean QTcB differences (ΔΔQTcF) of nemonoxacin 500 mg/750 mg groups and placebo group at corresponding time points with the manually measured QTcB in Lead II of ECG.
|
2 days
|
ECG analysis - baseline-adjusted mean QTcP
Time Frame: 2 days
|
To compare the post-dosing placebo-corrected, baseline-adjusted mean QTcP differences (ΔΔQTcF) of nemonoxacin 500 mg/750 mg groups and placebo group at corresponding time points with the manually measured QTcP in Lead II of ECG.
|
2 days
|
Safety analysis
Time Frame: 33 days
|
An analysis of adverse event (number and percentage of subjects) was conducted based on dosage groups
|
33 days
|
Maximum Plasma Concentration (Cmax)
Time Frame: 2 day
|
The analysis was conducted using the well-validated software (WinNolin and DAS programs).
A non-compartment model was used to analyze the plasma concentration-time data of nemonoxacin and moxifloxacin, thus the pharmacokinetic parameter was evaluated, and a descriptive summary of the plasma concentration-time data by dosage groups and time points were presented.
Also, a descriptive summary of pharmacokinetic parameters were made based on dosage groups.
|
2 day
|
Time at Which Maximum Plasma Concentration was Observed (Tmax)
Time Frame: 2 day
|
The analysis was conducted using the well-validated software (WinNolin and DAS programs).
A non-compartment model was used to analyze the plasma concentration-time data of nemonoxacin and moxifloxacin, thus the pharmacokinetic parameter was evaluated, and a descriptive summary of the plasma concentration-time data by dosage groups and time points were presented.
Also, a descriptive summary of pharmacokinetic parameters were made based on dosage groups.
|
2 day
|
Area Under the Plasma Concentration-Time Curve Calculated to the Last Measured Concentration (AUC(0~t))
Time Frame: 2 day
|
The analysis was conducted using the well-validated software (WinNolin and DAS programs).
A non-compartment model was used to analyze the plasma concentration-time data of nemonoxacin and moxifloxacin, thus the pharmacokinetic parameter was evaluated, and a descriptive summary of the plasma concentration-time data by dosage groups and time points were presented.
Also, a descriptive summary of pharmacokinetic parameters were made based on dosage groups.
|
2 day
|
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC(0~∞))
Time Frame: 2 day
|
The analysis was conducted using the well-validated software (WinNolin and DAS programs).
A non-compartment model was used to analyze the plasma concentration-time data of nemonoxacin and moxifloxacin, thus the pharmacokinetic parameter was evaluated, and a descriptive summary of the plasma concentration-time data by dosage groups and time points were presented.
Also, a descriptive summary of pharmacokinetic parameters were made based on dosage groups.
|
2 day
|
Lambda-z (λz)
Time Frame: 2 day
|
The analysis was conducted using the well-validated software (WinNolin and DAS programs).
A non-compartment model was used to analyze the plasma concentration-time data of nemonoxacin and moxifloxacin, thus the pharmacokinetic parameter was evaluated, and a descriptive summary of the plasma concentration-time data by dosage groups and time points were presented.
Also, a descriptive summary of pharmacokinetic parameters were made based on dosage groups.
|
2 day
|
half-life (t1/2)
Time Frame: 2 day
|
The analysis was conducted using the well-validated software (WinNolin and DAS programs).
A non-compartment model was used to analyze the plasma concentration-time data of nemonoxacin and moxifloxacin, thus the pharmacokinetic parameter was evaluated, and a descriptive summary of the plasma concentration-time data by dosage groups and time points were presented.
Also, a descriptive summary of pharmacokinetic parameters were made based on dosage groups.
|
2 day
|
Oral Clearance (CLt/F)
Time Frame: 2 day
|
The analysis was conducted using the well-validated software (WinNolin and DAS programs).
A non-compartment model was used to analyze the plasma concentration-time data of nemonoxacin and moxifloxacin, thus the pharmacokinetic parameter was evaluated, and a descriptive summary of the plasma concentration-time data by dosage groups and time points were presented.
Also, a descriptive summary of pharmacokinetic parameters were made based on dosage groups.
|
2 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 25, 2012
Primary Completion (ACTUAL)
August 10, 2012
Study Completion (ACTUAL)
August 10, 2012
Study Registration Dates
First Submitted
November 23, 2017
First Submitted That Met QC Criteria
November 29, 2017
First Posted (ACTUAL)
December 5, 2017
Study Record Updates
Last Update Posted (ACTUAL)
December 6, 2017
Last Update Submitted That Met QC Criteria
December 4, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TG-873870-C-7
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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