Influenza, HumanPhase 1NCT05720091
Substance Balance Study of [14C]ZX-7101A in Healthy Adult Male Subjects in China
A Phase 1 study testing ZX-7101A 80mg in people with Influenza, Human, run by Nanjing Zenshine Pharmaceuticals at 1 site in China.
Trial summary
The objectives of this substance balance study in healthy Chinese adult male subjects are to obtain human radioactivity recovery data and major excretion pathways, and to obtain pharmacokinetics of total radioactivity in plasma, and to identify major metabolites in the radiometabolite spectrum. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- ZX-7101A 80mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 14 Feb 2023to 25 Jul 2023
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The body mass index (BMI) is 19.0 to 26.0 kg/m2 (including the cut-off), and the subject must weigh no less than 50kg.
- Before the test, fully understand the test content, process and possible adverse reactions, and voluntarily sign the informed consent.
Who cannot join
- People with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product.
- Subjects with a pre-existing or present history of metabolic, liver, kidney, hematological, pulmonary, cardiovascular, gastrointestinal, urinary, endocrine, neurological, or psychiatric disease with clinical manifestations that the investigator deems unsuitable for participation in this study.
- Hemorrhoids or perianal disease with regular/ongoing blood in the stool, irritable bowel syndrome, inflammatory bowel disease.
- Screening for novel coronavirus infection: Those who are positive for novel coronavirus nucleic acid.
- Physical examination, vital signs, routine laboratory examination , thyroid function, chest CT, abdominal B-ultrasound and other tests were abnormal with clinical significance.
- Estimated glomerular filtration rate <90 mL/min/1.73 m2 (see Appendix 1 for eGFR formula).
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- Resting corrected QT interval (QTcF) ≥450ms, QRS≥120ms obtained by 12-lead electrocardiogram (ECG).
- Any conditions that may affect drug absorption, such as gastrectomy, cholecystectomy, gastric bypass, duodenotomy, colectomy, history of inflammatory bowel.
- Previous history of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmias, torsional ventricular tachycardia, ventricular tachycardia, atrioventricular block, history of prolonged QT syndrome, or symptoms of prolonged QT syndrome, and family history (indicated by genetic evidence or by sudden cardiac death at a young age in a close relative).
- Major surgery or surgical incision not fully healed within 6 months prior to the screening period; Major surgery includes, but is not limited to, any surgery where there is a significant risk of bleeding, prolonged period of general anesthesia, or open biopsy or significant traumatic injury.
- Use of any P-gp inducer or inhibitor within 30 days prior to the screening period; Have used any prescription drugs or Chinese herbs within 14 days prior to the screening period.
- Those who consumed more than 14 units of alcohol per week (1 unit of alcohol =360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine) within the six months prior to screening or tested positive for alcohol breath at the screening.
- Smokers who smoked more than 5 cigarettes a day or habitually used nicotine-containing products within the 3 months before screening and could not quit during the trial period.
- Subjects who tested serologically positive for antibodies to syphilis (Treponema pallidum), hepatitis B surface antigen or E antigen, hepatitis C virus antibody or human immunodeficiency virus antibody during the screening period.
- Those who had lost blood or donated 400 mL in the 3 months prior to the screening period or donated >200 mL within 4 weeks or planned to donate blood during the study period.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
About this study
Official title: A Study to Evaluate the Substance Balance of [14C] ZX-7101A in Healthy Adult Male Subjects in China
The objectives of this substance balance study in healthy Chinese adult male subjects are to obtain human radioactivity recovery data and major excretion pathways, and to obtain pharmacokinetics of total radioactivity in plasma, and to identify major metabolites in the radiometabolite spectrum. The main questions it aims to answer are:
- Quantitative analysis of total fecal and urine radioactivity in healthy subjects after oral administration of [14C]ZX-7101A to obtain human radioactive recovery data and main excretion routes.
- Pharmacokinetics of total activity in whole blood and plasma, and distribution of total activity in whole blood and plasma are quantitatively analyzed after oral administration of [14C]ZX-7101A in healthy subjects.
- Quantitative analysis of the radioactive metabolites in plasma, urine and feces of healthy subjects with once [14C]ZX-7101A orally administration, identification of the main metabolites of the radioactive metabolites (close to or greater than 10% of the total radioactive AUC in plasma), and determination of the main biotransformation and elimination pathway of ZX-7101A.
- Conditions
- Influenza, Human
- Being tested
- ZX-7101A 80mg
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZX-7101A 80mgDrug
a drug to treatment influenza in Chinese adults
| Study group | Role | What they receive |
|---|---|---|
| ZX-7101A | Experimental | Not described Receives: Drug: ZX-7101A 80mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative recovery of total radioactive material in urine and feces
The total radioactivity in excreta of healthy subjects after oral administration of [14C]ZX-7101A
Measured: From 1 days before medication to 22 days after medication
Cmax of total radioactivity in plasma
The peak concentration of ZX-7101A after oral administration of [14C]ZX-7101A in healthy subjects
Measured: From 1 days before medication to 22 days after medication
AUC of total radioactivity in plasma
The area under curve of ZX-7101A after oral administration of [14C]ZX-7101A in healthy subjects
Measured: From 1 days before medication to 22 days after medication
Secondary outcomes (1)
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
The Treatment-Related Adverse Events of ZX-7101A will be evaluated by the change of vital signs, electrocardiogram (P Wave, QRS Complex, QT Interval), physical examination, and Laboratory test compared with the baseline.
Measured: From medication to 22 days after medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start14 Feb 2023
- Primary completion20 Mar 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Zenshine Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- liyan Miao, doctor, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720091
- Sponsor's protocol ID
- ZX-7101A-204
- Status last verified
- Nov 2024
- First submitted
- 16 Jan 2023
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Substance Balance of [14C] ZX-7101A in Healthy Adult Male Subjects in China
- ClinicalTrials.gov ID
- NCT05720091
- Acronym / sponsor ID
- ZX-7101A-204
- Conditions
- Influenza, Human
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Nanjing Zenshine PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 9 Feb 2023 (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.
The objectives of this substance balance study in healthy Chinese adult male subjects are to obtain human radioactivity recovery data and major excretion pathways, and to obtain pharmacokinetics of total radioactivity in plasma, and to identify major metabolites in the radiometabolite spectrum. The main questions it aims to answer are:
- Quantitative analysis of total fecal and urine radioactivity in healthy subjects after oral administration of [14C]ZX-7101A to obtain human radioactive recovery data and main excretion routes.
- Pharmacokinetics of total activity in whole blood and plasma, and distribution of total activity in whole blood and plasma are quantitatively analyzed after oral administration of [14C]ZX-7101A in healthy subjects.
- Quantitative analysis of the radioactive metabolites in plasma, urine and feces of healthy subjects with once [14C]ZX-7101A orally administration, identification of the main metabolites of the radioactive metabolites (close to or greater than 10% of the total radioactive AUC in plasma), and determination of the main biotransformation and elimination pathway of ZX-7101A.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ZX-7101A | Experimental | Drug: ZX-7101A 80mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- The body mass index (BMI) is 19.0 to 26.0 kg/m2 (including the cut-off), and the subject must weigh no less than 50kg.
- Before the test, fully understand the test content, process and possible adverse reactions, and voluntarily sign the informed consent.
Key exclusion criteria (15 listed)
- People with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product.
- Subjects with a pre-existing or present history of metabolic, liver, kidney, hematological, pulmonary, cardiovascular, gastrointestinal, urinary, endocrine, neurological, or psychiatric disease with clinical manifestations that the investigator deems unsuitable for participation in this study.
- Hemorrhoids or perianal disease with regular/ongoing blood in the stool, irritable bowel syndrome, inflammatory bowel disease.
- Screening for novel coronavirus infection: Those who are positive for novel coronavirus nucleic acid.
- Physical examination, vital signs, routine laboratory examination , thyroid function, chest CT, abdominal B-ultrasound and other tests were abnormal with clinical significance.
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 |
|---|---|---|
| ZX-7101A 80mga drug to treatment influenza in Chinese adults | Drug | ZX-7101A |
Primary outcome
Cumulative recovery of total radioactive material in urine and feces
Time frame: From 1 days before medication to 22 days after medication
The total radioactivity in excreta of healthy subjects after oral administration of [14C]ZX-7101A
Cmax of total radioactivity in plasma
Time frame: From 1 days before medication to 22 days after medication
The peak concentration of ZX-7101A after oral administration of [14C]ZX-7101A in healthy subjects
AUC of total radioactivity in plasma
Time frame: From 1 days before medication to 22 days after medication
The area under curve of ZX-7101A after oral administration of [14C]ZX-7101A in healthy subjects
1 secondary outcome
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time frame: From medication to 22 days after medication
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 5 Nov 2024.
- Individual participant dataSharing planned: No
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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.
liyan Miao, doctor principal investigator
The First Affiliated Hospital of Soochow University
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 ZX-7101A 80mg in people with Influenza, Human, run by Nanjing Zenshine Pharmaceuticals 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 2 inclusion and 15 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 5 Nov 2024. 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?
Cumulative recovery of total radioactive material in urine and feces (time frame: From 1 days before medication to 22 days after medication). The study lists 3 primary outcomes in all. 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 5 Nov 2024.