Liver DysfunctionPhase 1NCT02604498
Pharmacokinetics Study of Nemonoxacin Malate Capsules in Subjects With Moderate Impaired Hepatic Function
A Phase 1 study testing Nemonoxacin in people with Liver Dysfunction, run by Zhejiang Medicine Co., Ltd. at 1 site in China.
Trial summary
This is a single center, open-label, non-randomized, 1:1 parallel control and single dose administration study design. Healthy subjects will be matched to moderate hepatic function impaired (Child-Pugh B，7-9) subjects in age, gender and weight as parallel control, which matches healthy with normal hepatic function… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Dysfunction
- What is being tested?
- Nemonoxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 14 Apr 2016to 15 Jan 2018
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with hepatic impairment
- male or female aged 18 to 70 years；
- has a body mass index of 17 to 30 kg/m2；
- eGRF>50ml/min/1.73m2；
- Patients in stable condition with moderate impaired hepatic function, due to viral hepatitis, alcoholic liver disease, autoimmune hepatitis, primary biliary cirrhosis or other causes, and determined to be level B according to Child-Pugh classification；
- B-ultrasonography, CT or MRI shows or biopsy confirm that have a positive diagnosis of cirrhosis ；
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- Has stable regimen of treatment of hepatic function impaired for 3 months prior to enrollment;
- Female volunteers must meet:
- Has sterilization operation, or who are postmenopausal must have been postmenopausal for >1 year, or
- Has childbearing potential, but meet the requirement as following:
- Negative pregnancy test prior to enrollment, and Agree with use 1 medical accepted methods of birth control (eg. Hormonal contraceptive, barrier contraceptive with additional spermicide, or an intrauterine device) during the whole study and continuing until 1 month after the end of the study, and Non-breastfeeding;
- Male volunteers must agree to use medical accepted method of birth control (e.g. barrier contraceptive or sexual partner use the method as (7) above) during the study and through 1month after the end of study；
- Agree stay in ward prior to dosing within 48h, and agree not to take coffee, tea, chocolate, alcohol, grapefruit juice, orange juice and other food and drink which contain caffeine and xanthine；
- Can sign informed consent form on his own accord；
- Can comply with study procedures
- Healthy subjects without hepatic impairment
- Male or female volunteers (matched to a subject with hepatic impairment in gender）；
- Aged 18 to 70 years (matched to a subject with hepatic impairment±5 years, matched range cannot exceed±5 years)；
- Has a body mass index of 17 to 30 kg/m2（matched to a subject with hepatic impairment±15%，matched range cannot exceed±15%）；
- Must be in good health as determined by screening medical history, physical examination, vital signs, laboratory test, B ultrasonography and chest X ray；
- Female volunteers must meet:
- Has sterilization operation, or who are postmenopausal must have been postmenopausal for >1 year, or
- Has childbearing potential, but meet the requirement as following:
- Negative pregnancy test prior to enrollment, and Agree with use 1 medical accepted methods of birth control (eg. Hormonal contraceptive, barrier contraceptive with additional spermicide, or an intrauterine device) during the whole study and continuing until 1month after the end of the study, and Non-breastfeeding；
- Male volunteers must agree to use medical accepted method of birth control (e.g. barrier contraceptive or sexual partner use the method as (7) above) during the study and through 1month after the end of study；
- Agree stay in ward prior to dosing within 48h, and agree not to take coffee, tea, chocolate, alcohol, grapefruit juice, orange juice and other food and drink which contain caffeine and xanthine；
- Can sign informed consent form on his own accord；
- Can comply with study procedures
Who cannot join
- Subjects with hepatic impairment
- Has known or suspected allergies to quinolones, fluoroquinolones, Nemonoxacin or excipients or allergic constitution；
- Has acute disease or chronic disease which may affect PK profile of drug in vivo except the disease caused hepatic function impaired；
- Has abnormal result of laboratory tests with clinical significance except which caused by the disease of hepatic function impaired；
- Has history of clinically significant cardiovascular, neurological or psychiatric, gastrointestinal, pulmonary, renal, endocrine disease prior to study within 1 year；
- Has disease seriously affect the immune system such as hematological disease, malignant tumor, or taking immunosuppressant；
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- Has acute or sub-acute hepatic function failure；
- Has experienced esophageal variceal bleeding within the past 6 months；
- Has advanced ascites or spontaneous bacterial peritonitis；
- Has a history of Gilbert's disease；
- Has resistance or liver function abnormal after orally taking nucleoside analogue, an antiviral drug；
- Stop taking nucleoside analogue, an antiviral drug within 1 year；
- Has total bilirubin>3×upper limit of normal (ULN) and without cholestasis; alkaline phosphatase (ALP)>2×ULN；
- Alanine Aminotransferase (ALT)or Aspartate Aminotransferase（AST）>5×ULN；
- ALT or AST>3×ULN with total bilirubin>2×ULN；
- international senstibity index，INR≥1.5 or prothrombin time activity≤40%；
- Child-Pugh assessed as C level；
- Has a history of alcoholism within 2 years prior to dosing; drink≥12 times within 3 months prior dosing; alcohol test positive as screening；
- Has history of drug misuse within 2 years prior to dosing; urine drug screen positive；
- Has history of taking products of tobacco or nicotine more than 5 cigarettes/day within 1 month prior to dosing, or cannot stop smoking during the study;
- Use of another investigational drug or drug which can damage hepatic function within 3 months prior to dosing；
- Use of drugs affect function of liver metabolism enzyme (e.g. benzene, isopropyl amine, the barbiturates benzodiazepines, marijuana, cocaine, opiates and phencyclidine) within 30 days prior to dosing ；
- Has to take the drug which may affect the PK profile of investigate drug (e.g. antacids, sucralfate, metal cation, calcium supplements, warfarin, non-steroidal anti-inflammatory drugs, theophylline, cyclosporine, probenecid and cimetidine) ；
- Has gastrointestinal disease or malabsorption syndrome affecting drug Absorb；
- Has history of seizures or central nervous system disease which the investigator considers to interfere with compliancy of protocol; or has risk of suicide；
- Clinical significant abnormal 12-lead electrocardiograms (ECGs) at screening (eg. atrioventricular block, torsades de pointes ventricular tachycardia (TdT), and other types of ventricular tachycardia, ventricular fibrillation, ventricular flutter, T wave change with clinical significance or any abnormal results of 12-lead ECG which affect QTc interphase) ；
- HIV or syphilis RPR test positive；
- Conditions investigator consider not suitable to be enrolled in the study. Healthy subjects without hepatic impairment
- <!-- -->
- Has known or suspected allergies to quinolones, fluoroquinolones, nemonoxacin or excipients or allergic constitution；
- Has a history of alcoholism within 2 years prior to dosing; drink≥12 times within 3 months prior dosing; alcohol test positive as screening；
- Has history of drug misuse within 2 years prior to dosing; urine drug screen positive；
- Has history of taking products of tobacco or nicotine more than 5 cigarettes/day within 1 month prior to dosing, or cannot stop smoking during the study；
- Donated blood or use of another investigational drug within 3 months prior to dosing；
- Has history of chronic liver, renal, cardiovascular, neurological or psychiatric, gastrointestinal, pulmonary, urinary, endocrine disease cannot controlled by drugs；
- Use of drugs affect function of liver metabolism enzyme within 30 days prior to dosing; or need to take medications which may affect the PK profile of investigational drug (including: products containing Calcium, aluminum, magnesium, iron and zinc, sucralfate, antacid, nutrition supplements, Vitamins and metal supplements) during the study；
- Is taking any antibacterial agents or prophylaxis or treatment drugs；
- HIV-Ab, HBsAg ,HCV-Ab or syphilis RPR positive；
- Clinical significant abnormal 12-lead electrocardiograms (ECGs) at screening (eg. atrioventricular block, torsades de pointes ventricular tachycardia (TdT), and other types of ventricular tachycardia, ventricular fibrillation, ventricular flutter, T wave change with clinical significance or QTc>450ms) ；
- Has abnormal result of laboratory test with clinical significance assessed by investigator at screening；
- Has gastrointestinal disease or malabsorption syndrome affecting drug Absorb；
- Has history of seizures or central nervous system disease which the investigator considers to interfere with compliancy of protocol; or has risk of suicide；
- Has any antibacterials, glucocorticoids, immunosuppressive agents or drug may damage organs within 14 days prior to dosing；
- Cannot orally take drug；
- Has history of or currently has disease and condition may affect the safety and efficancy assessment of investigational drug judged by investigator；
- Is a member of the clinical site personnel directly affiliated with this study；
- Conditions investigator consider not suitable to be enrolled in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 20040
About this study
This is a single center, open-label, non-randomized, 1:1 parallel control and single dose administration study design. Healthy subjects will be matched to moderate hepatic function impaired (Child-Pugh B，7-9) subjects in age, gender and weight as parallel control, which matches healthy with normal hepatic function according to the of subjects with impaired hepatic function as, after enrollment of subjects with moderate impaired hepatic function (Child-Pugh B，7-9). Hepatic function impaired group and control group both receive orally single-dose of nemonoxacin malate capsule (0.5g). Collect the blood and urine samples before and after the administration to perform pharmacokinetic analysis and safety observation.
Read the detailed description
Single dose study: evaluate safety and tolerability of oral nemonoxacin capsule 500mg.
- Conditions
- Liver Dysfunction
- Being tested
- Nemonoxacin
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NemonoxacinDrug
Also called Nemonoxacin Malate Capsules
Single dose 500mg oral
| Study group | Role | What they receive |
|---|---|---|
| Liver function impaired | Experimental | Subject with Moderate Impaired Hepatic Function. Nemonoxacin Malate Capsules 500mg single dose oral. Receives: Drug: Nemonoxacin |
| Healthy Subjects | Experimental | Healthy volunteers. Nemonoxacin Malate Capsules 500mg single dose oral. Receives: Drug: Nemonoxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in Moderate Impaired Hepatic Function: maximum plasma drug concentration ( Cmax)
Measured: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in Moderate Impaired Hepatic Function: time at which maximum plasma concentration is observed (Tmax)
Measured: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in Moderate Impaired Hepatic Function: area under the plasma concentration vs. time curve (AUC0-t and AUC0-∞)
Measured: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in Moderate Impaired Hepatic Function:elimination half-life (t1/2)
Measured: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in Moderate Impaired Hepatic Function:mean dissolution time (MRT)
Measured: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in Moderate Impaired Hepatic Function: total clearance of the drug from plasma (CLz/F)
Measured: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in Moderate Impaired Hepatic Function: Apparent Volume of Distribution (Vz/F)
Measured: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in Moderate Impaired Hepatic Function: cumulative amount of unchanged drug excreted into the urine (Ae Urine 0-24h,0-72h）
Measured: Within 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in Moderate Impaired Hepatic Function:renal clearance of the drug from plasma (CLr)
Measured: Within 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in Moderate Impaired Hepatic Function: minimum plasma drug concentration (Cmin)
Measured: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
Secondary outcomes (5)
Safety assessed by AEs
reported spontaneously or not by leading questions
Measured: up to 72 hours after study drug dosing
Safety assessed by vital signs
blood pressure, pulse rate, respiratory rate and body temperature
Measured: up to 72 hours after study drug dosing
Safety assessed by laboratory tests
Hematology, blood biochemistry,cogulation test and urinalysis
Measured: up to 72 hours after study drug dosing
Safety assessed by physical examination
(1) general appearance (2) skin (3) head and neck (4)chest, including heart, pulmonary and breast (5) abdomen, including stomach and intestines, liver and gallbladder (6) back (7) Urinary tract (8) extremity (9) neurological or psychiatric system (10) lymph gland (11)others.
Measured: up to 72 hours after study drug dosing
Safety assessed by 12-lead ECGs
Measured: up to 72 hours after study drug dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study start14 Apr 2016
- Primary completion15 Jan 2018
- Study completion15 Jan 2018
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 Liver DysfunctionStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Huashan Hospital
- Responsible party
- Sponsor
- Investigators
- Jing Zhang, Doctor, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604498
- Sponsor's protocol ID
- XCNN-150830-1
- Status last verified
- Mar 2018
- First submitted
- 3 Nov 2015
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Kang Y, Li Y, Xu F, Zhang J, Wang K, Chen Y, Wu J, Guo B, Yu J, Zhang Y. Population Pharmacokinetics Study of Nemonoxacin Among Chinese Patients With Moderate Hepatic Impairment. Clin Ther. 2019 Mar;41(3):505-517.e0. doi: 10.1016/j.clinthera.2019.01.015. Epub 2019 Feb 26.
PubMed 30819510
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics Study of Nemonoxacin Malate Capsules in Subjects With Moderate Impaired Hepatic Function
- ClinicalTrials.gov ID
- NCT02604498
- Acronym / sponsor ID
- XCNN-150830-1
- Conditions
- Liver Dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Zhejiang Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Huashan Hospital
- Study start
- 14 Apr 2016 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 13 Nov 2015 (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.
This is a single center, open-label, non-randomized, 1:1 parallel control and single dose administration study design. Healthy subjects will be matched to moderate hepatic function impaired (Child-Pugh B，7-9) subjects in age, gender and weight as parallel control, which matches healthy with normal hepatic function according to the of subjects with impaired hepatic function as, after enrollment of subjects with moderate impaired hepatic function (Child-Pugh B，7-9). Hepatic function impaired group and control group both receive orally single-dose of nemonoxacin malate capsule (0.5g). Collect the blood and urine samples before and after the administration to perform pharmacokinetic analysis and safety observation.
Detailed description
Single dose study: evaluate safety and tolerability of oral nemonoxacin capsule 500mg.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liver function impaired | Experimental | Drug: NemonoxacinSubject with Moderate Impaired Hepatic Function. Nemonoxacin Malate Capsules 500mg single dose oral. |
| Healthy Subjects | Experimental | Drug: NemonoxacinHealthy volunteers. Nemonoxacin Malate Capsules 500mg single dose oral. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Subjects with hepatic impairment
- Negative pregnancy test prior to enrollment, and Agree with use 1 medical accepted methods of birth control (eg. Hormonal contraceptive, barrier contraceptive with additional spermicide, or an intrauterine device) during the whole study and continuing until 1 month after the end of the study, and Non-breastfeeding;
- Healthy subjects without hepatic impairment
- Male or female volunteers (matched to a subject with hepatic impairment in gender）；
- Aged 18 to 70 years (matched to a subject with hepatic impairment±5 years, matched range cannot exceed±5 years)；
Key exclusion criteria (47 listed)
- Subjects with hepatic impairment
- <!-- -->
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 |
|---|---|---|
| NemonoxacinAlso: Nemonoxacin Malate CapsulesSingle dose 500mg oral | Drug | Healthy Subjects, Liver function impaired |
Primary outcome
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in Moderate Impaired Hepatic Function: maximum plasma drug concentration ( Cmax)
Time frame: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in Moderate Impaired Hepatic Function: time at which maximum plasma concentration is observed (Tmax)
Time frame: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in Moderate Impaired Hepatic Function: area under the plasma concentration vs. time curve (AUC0-t and AUC0-∞)
Time frame: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in Moderate Impaired Hepatic Function:elimination half-life (t1/2)
Time frame: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in Moderate Impaired Hepatic Function:mean dissolution time (MRT)
Time frame: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in Moderate Impaired Hepatic Function: total clearance of the drug from plasma (CLz/F)
Time frame: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in Moderate Impaired Hepatic Function: Apparent Volume of Distribution (Vz/F)
Time frame: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in Moderate Impaired Hepatic Function: cumulative amount of unchanged drug excreted into the urine (Ae Urine 0-24h,0-72h）
Time frame: Within 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in Moderate Impaired Hepatic Function:renal clearance of the drug from plasma (CLr)
Time frame: Within 72h after dosing
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in Moderate Impaired Hepatic Function: minimum plasma drug concentration (Cmin)
Time frame: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing
5 secondary outcomes
Safety assessed by AEs
Time frame: up to 72 hours after study drug dosing
Safety assessed by vital signs
Time frame: up to 72 hours after study drug dosing
Safety assessed by laboratory tests
Time frame: up to 72 hours after study drug dosing
Safety assessed by physical examination
Time frame: up to 72 hours after study drug dosing
Safety assessed by 12-lead ECGs
Time frame: up to 72 hours after study drug dosing
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 30 Mar 2018.
- Derived from this study: PubMed 30819510Kang Y, Li Y, Xu F, Zhang J, Wang K, Chen Y, Wu J, Guo B, Yu J, Zhang Y. Population Pharmacokinetics Study of Nemonoxacin Among Chinese Patients With Moderate Hepatic Impairment. Clin Ther. 2019 Mar;41(3):505-517.e0. doi: 10.1016/j.clinthera.2019.01.015. Epub 2019 Feb 26.
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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.
Jing Zhang, Doctor principal investigator
Huashan Hospital
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 Nemonoxacin in people with Liver Dysfunction, run by Zhejiang Medicine Co., Ltd. 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 28 inclusion and 47 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 30 Mar 2018. 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. 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?
Pharmacokinetics (PK) parameters of single oral dose of nemonoxacin in Moderate Impaired Hepatic Function: maximum plasma drug concentration ( Cmax) (time frame: Pre-dose, 0.5h,1h, 1.5h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h after dosing). The study lists 10 primary outcomes in all. 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 NCT02604498, 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 30 Mar 2018.