Healthy VolunteersPhase 1NCT03362853
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
A Phase 1 study testing Nemonoxacin 500Mg Capsule, Moxifloxacin 400Mg Tablet and Nemonoxacin 750Mg Capsule in people with Healthy Volunteers, run by TaiGen Biotechnology Co., Ltd..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Nemonoxacin 500Mg Capsule, Moxifloxacin 400Mg Tablet and Nemonoxacin 750Mg Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 25 Jun 2012to 10 Aug 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
About this study
Official title: 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.
- Conditions
- Healthy Volunteers
- Being tested
- Nemonoxacin 500Mg Capsule, Moxifloxacin 400Mg Tablet, Nemonoxacin 750Mg Capsule, Placebo oral capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nemonoxacin 500Mg CapsuleDrug
Also called TG-873870 500Mg
Receive a single dose in a fasting state
Moxifloxacin 400Mg TabletDrug
Receive a single dose in a fasting state
Nemonoxacin 750Mg CapsuleDrug
Also called TG-873870 750Mg
Receive a single dose in a fasting state
Placebo oral capsuleDrug
Receive a single dose in a fasting state
| Study group | Role | What they receive |
|---|---|---|
| Nemonoxacin 500Mg Capsule | Experimental | Not described Receives: Drug: Nemonoxacin 500Mg Capsule; Drug: Moxifloxacin 400Mg Tablet; Drug: Nemonoxacin 750Mg Capsule; Drug: Placebo oral capsule |
| Nemonoxacin 750Mg Capsule | Experimental | Not described Receives: Drug: Nemonoxacin 500Mg Capsule; Drug: Moxifloxacin 400Mg Tablet; Drug: Nemonoxacin 750Mg Capsule; Drug: Placebo oral capsule |
| Placebo oral capsule | Placebo comparator | Not described Receives: Drug: Nemonoxacin 500Mg Capsule; Drug: Moxifloxacin 400Mg Tablet; Drug: Nemonoxacin 750Mg Capsule; Drug: Placebo oral capsule |
| Moxifloxacin 400Mg Tablet | Active comparator | Not described Receives: Drug: Nemonoxacin 500Mg Capsule; Drug: Moxifloxacin 400Mg Tablet; Drug: Nemonoxacin 750Mg Capsule; Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECG analysis - baseline-adjusted mean QTcF
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.
Measured: 2 days
Secondary outcomes (10)
ECG analysis - baseline-adjusted mean QTcB
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.
Measured: 2 days
ECG analysis - baseline-adjusted mean QTcP
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.
Measured: 2 days
Safety analysis
An analysis of adverse event (number and percentage of subjects) was conducted based on dosage groups
Measured: 33 days
Maximum Plasma Concentration (Cmax)
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.
Measured: 2 day
Time at Which Maximum Plasma Concentration was Observed (Tmax)
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.
Measured: 2 day
Area Under the Plasma Concentration-Time Curve Calculated to the Last Measured Concentration (AUC(0~t))
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.
Measured: 2 day
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC(0~∞))
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.
Measured: 2 day
Lambda-z (λz)
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.
Measured: 2 day
half-life (t1/2)
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.
Measured: 2 day
Oral Clearance (CLt/F)
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.
Measured: 2 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start25 Jun 2012
- Primary completion10 Aug 2012
- Study completion10 Aug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- TaiGen Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362853
- Sponsor's protocol ID
- TG-873870-C-7
- Status last verified
- Dec 2017
- First submitted
- 23 Nov 2017
- Last updated
- 6 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhao C, Lv Y, Li X, Hou F, Ma X, Wei M, Kang Z, Cui L, Xia Y, Liu Y, Tian J. Effects of Nemonoxacin on Thorough ECG QT/QTc Interval: A Randomized, Placebo- and Positive-controlled Crossover Study in Healthy Chinese Adults. Clin Ther. 2018 Jun;40(6):983-992. doi: 10.1016/j.clinthera.2018.04.014. Epub 2018 May 24.
PubMed 29803534
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03362853
- Acronym / sponsor ID
- TG-873870-C-7
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- TaiGen Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2012 (actual)
- Primary completion
- 10 Aug 2012 (actual)
- Study completion
- 10 Aug 2012 (actual)
- First posted
- 5 Dec 2017 (actual)
- 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nemonoxacin 500Mg Capsule | Experimental | Drug: Nemonoxacin 500Mg Capsule, Drug: Moxifloxacin 400Mg Tablet, Drug: Nemonoxacin 750Mg Capsule, Drug: Placebo oral capsule |
| Nemonoxacin 750Mg Capsule | Experimental | Drug: Nemonoxacin 500Mg Capsule, Drug: Moxifloxacin 400Mg Tablet, Drug: Nemonoxacin 750Mg Capsule, Drug: Placebo oral capsule |
| Placebo oral capsule | Placebo comparator | Drug: Nemonoxacin 500Mg Capsule, Drug: Moxifloxacin 400Mg Tablet, Drug: Nemonoxacin 750Mg Capsule, Drug: Placebo oral capsule |
| Moxifloxacin 400Mg Tablet | Active comparator | Drug: Nemonoxacin 500Mg Capsule, Drug: Moxifloxacin 400Mg Tablet, Drug: Nemonoxacin 750Mg Capsule, Drug: Placebo oral capsule |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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:
- 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.
Key exclusion criteria (21 listed)
- 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
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 |
|---|---|---|
| Nemonoxacin 500Mg CapsuleAlso: TG-873870 500MgReceive a single dose in a fasting state | Drug | Moxifloxacin 400Mg Tablet, Nemonoxacin 500Mg Capsule, Nemonoxacin 750Mg Capsule, Placebo oral capsule |
| Moxifloxacin 400Mg TabletReceive a single dose in a fasting state | Drug | Moxifloxacin 400Mg Tablet, Nemonoxacin 500Mg Capsule, Nemonoxacin 750Mg Capsule, Placebo oral capsule |
| Nemonoxacin 750Mg CapsuleAlso: TG-873870 750MgReceive a single dose in a fasting state | Drug | Moxifloxacin 400Mg Tablet, Nemonoxacin 500Mg Capsule, Nemonoxacin 750Mg Capsule, Placebo oral capsule |
| Placebo oral capsuleReceive a single dose in a fasting state | Drug | Moxifloxacin 400Mg Tablet, Nemonoxacin 500Mg Capsule, Nemonoxacin 750Mg Capsule, Placebo oral capsule |
Primary outcome
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.
10 secondary outcomes
ECG analysis - baseline-adjusted mean QTcB
Time frame: 2 days
ECG analysis - baseline-adjusted mean QTcP
Time frame: 2 days
Safety analysis
Time frame: 33 days
Maximum Plasma Concentration (Cmax)
Time frame: 2 day
Time at Which Maximum Plasma Concentration was Observed (Tmax)
Time frame: 2 day
Area Under the Plasma Concentration-Time Curve Calculated to the Last Measured Concentration (AUC(0~t))
Time frame: 2 day
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC(0~∞))
Time frame: 2 day
Lambda-z (λz)
Time frame: 2 day
half-life (t1/2)
Time frame: 2 day
Oral Clearance (CLt/F)
Time frame: 2 day
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 6 Dec 2017.
- Derived from this study: PubMed 29803534Zhao C, Lv Y, Li X, Hou F, Ma X, Wei M, Kang Z, Cui L, Xia Y, Liu Y, Tian J. Effects of Nemonoxacin on Thorough ECG QT/QTc Interval: A Randomized, Placebo- and Positive-controlled Crossover Study in Healthy Chinese Adults. Clin Ther. 2018 Jun;40(6):983-992. doi: 10.1016/j.clinthera.2018.04.014. Epub 2018 May 24.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nemonoxacin 500Mg Capsule, Moxifloxacin 400Mg Tablet and Nemonoxacin 750Mg Capsule in people with Healthy Volunteers, run by TaiGen Biotechnology Co., Ltd..
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 12 inclusion and 21 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 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
ECG analysis - baseline-adjusted mean QTcF (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03362853, which also lists 1 linked publication.
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 6 Dec 2017.