Drug InteractionPhase 1ZX-7101A-208NCT06057103
A Study to Evaluate Drug-drug Interaction of ZX-7101A Tablets and Oseltamivir Phosphate Capsules in Healthy Adult Subjects
A Phase 1 study testing ZX-7101A, Oseltamivir and ZX-7101A and Oseltamivir in people with Drug Interaction, run by Nanjing Zenshine Pharmaceuticals at 1 site in China.
Trial summary
The primary object of this study is evaluating the effect of multiple oral oseltamivir phosphate capsules on the pharmacokinetic profile of the active metabolite ZX-7101 after a single oral administration of ZX-7101A tablet in healthy Chinese adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Interaction
- What is being tested?
- ZX-7101A, Oseltamivir and ZX-7101A and Oseltamivir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 28 Aug 2023to 26 Apr 2024
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects between the ages of 18 and 45 years (including the threshold value, based on the date of signing ICF).
- Weight: Male weight ≥50 kg, female weight ≥45 kg, BMI between 19.0 and 28.0 kg/m2 (including cut-off value), BMI= weight (kg)/height 2 (m2).
- The investigator judged the subjects to be in good overall health based on their medical history, physical examination, vital signs, 12-lead electrocardiogram, laboratory tests (routine blood work, urine work, blood biochemistry, coagulation function), viral serology, and chest X-ray results (normal or abnormal test results have no clinical significance).
- Fertile female subjects or male subjects who voluntarily signed ICF should be no fertile, sperm/egg donation for 6 months (female) or 90 days (male) from the beginning to the last dose, and voluntary use highly effective contraception (including partner) (non-drug contraception is required during the trial).
- Fully understand the trial content and possible adverse reactions, have the ability to communicate with researchers normally, while complying with study requirements, follow protocol procedures and restrictions, and be able to visit on time.
Who cannot join
- Subjects with a prior or present history of clinically abnormal metabolic, liver, kidney, hematological, pulmonary, cardiovascular, gastrointestinal, urinary, endocrine, neurological, or psychiatric disease who were judged by the investigator to be unsuitable for participation in this study.
- Subjects with digestive tract disease or any condition that may affect drug absorption, such as a history of liver and gallbladder disease, gastrointestinal disease, gastrointestinal surgery (except appendectomy) or a history of chronic pancreatitis, idiopathic acute pancreatitis, or habitual diarrhea.
- Allergic constitutions (such as allergies to two or more drugs, foods, and pollen), or determined by the investigator, may be allergic to the investigational product or any component of the investigational product.
- Acute respiratory infections within 2 weeks before screening; Or have a history of fungal infection.
- For patients with abnormal vital signs (blood pressure, pulse rate, ear temperature) and clinically significant results, the abnormal values of each vital sign are:Body temperature (ear temperature) >37.5 ℃; Systolic blood pressure (recumbent) <90 mmHg or ≥140 mmHg; Diastolic blood pressure (lying) <50 mmHg or ≥90 mmHg; Pulse rate (lying position) <50 beats/min or >100 beats/min.
- QTcF interval > 450ms or < 300 ms (Fridericia's correction), or QRS>120ms. Abnormal liver function: alanyl aminotransferase (ALT) or aspartate aminotransferase (AST) higher than the upper limit of normal or serum total bilirubin (TBIL) greater than 1.5 times the upper limit of normal, who judged clinical significance by investigators.
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- Subjects estimate glomerular filtration rate <90 mL/min/1.73 m2. Subjects virus serological test (hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, treponema pallidum specific antibody TPPA) positive results.
- Subjects with a history of drug abuse (morphine, dimethylene dioxyamphetamine, methamphetamine, THC, ketamine, cocaine) or who screened positive for drug abuse.
- Women who are pregnant or breastfeeding, or who test positive for blood pregnancy.
- Subjects who have used any P-gp or CYP inducer or inhibitor within 30 days before screening, or any prescription or Chinese herbal medicine within 4 weeks before the start of the trial, or over-the-counter or health care products (including polyvalent cations and metal supplements, etc.) within 2 weeks before the start of the trial; It should have a longer time interval if the elimination half-life is longer-at least 5 elimination half-lives for the drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate Drug-drug Interaction of ZX-7101A Tablets and Oseltamivir Phosphate Capsules in Healthy Adult Subjects -a Single-center, Open-labelled, Six-sequence, Three-cycle Crossover Design
The primary object of this study is evaluating the effect of multiple oral oseltamivir phosphate capsules on the pharmacokinetic profile of the active metabolite ZX-7101 after a single oral administration of ZX-7101A tablet in healthy Chinese adult subjects.
The seongdary object is evaluating combined or uncombined multiple oral oseltamivir phosphate in healthy Chinese adult subjects.
- Conditions
- Drug Interaction
- Being tested
- ZX-7101A, Oseltamivir, ZX-7101A and Oseltamivir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZX-7101ADrug
ZX-7101A Tablets single dose tablet, 80 mg, Oral
OseltamivirDrug
Oseltamivir phosphate capsule was administered as a single drug, 75 mg twice daily, for 5 days,Oral
ZX-7101A and OseltamivirDrug
ZX-7101A tablet (80mg, single dose) was combined with oseltamivir phosphate capsule (75 mg twice daily),Oral
ZX-7101ADrug
ZX-7101A Tablets single dose tablet, 80 mg, Oral
OseltamivirDrug
Oseltamivir phosphate capsule was administered as a single drug, 75 mg twice daily, for 5 days,Oral
ZX-7101A and OseltamivirDrug
ZX-7101A tablet (80mg, single dose) was combined with oseltamivir phosphate capsule (75 mg twice daily),Oral
ZX-7101ADrug
ZX-7101A Tablets single dose tablet, 80 mg, Oral
| Study group | Role | What they receive |
|---|---|---|
| ZX-7101A-1 | Other | Not described Receives: Drug: ZX-7101A; Drug: Oseltamivir; Drug: ZX-7101A and Oseltamivir |
| ZX-7101A-2 | Other | Not described Receives: Drug: ZX-7101A; Drug: ZX-7101A and Oseltamivir; Drug: Oseltamivir |
| Oseltamivir-1 | Other | Not described Receives: Drug: Oseltamivir; Drug: ZX-7101A; Drug: ZX-7101A and Oseltamivir |
| Oseltamivir-2 | Other | Not described Receives: Drug: Oseltamivir; Drug: ZX-7101A and Oseltamivir; Drug: ZX-7101A |
| Combined-1 | Other | Not described Receives: Drug: ZX-7101A and Oseltamivir; Drug: ZX-7101A; Drug: Oseltamivir |
| Combined-2 | Other | Not described Receives: Drug: ZX-7101A and Oseltamivir; Drug: Oseltamivir; Drug: ZX-7101A |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters of active metabolite ZX-7101 in healthy Chinese adult subjects after a single oral ZX-7101A tablet combined with multiple oral oseltamivir phosphate capsules
Cmax
Measured: Day1,Day2,Day3,Day5,Day10,Day15,Day20;Conbined period Day1,Day2,Day3,Day6,Day10,Day15,Day20
PK parameters of active metabolite ZX-7101 in healthy Chinese adult subjects after a single oral ZX-7101A tablet combined with multiple oral oseltamivir phosphate capsules
AUC0-t
Measured: Day1,Day2,Day3,Day5,Day10,Day15,Day20;Conbined period Day1,Day2,Day3,Day6,Day10,Day15,Day20
PK parameters of active metabolite ZX-7101 in healthy Chinese adult subjects after a single oral ZX-7101A tablet combined with multiple oral oseltamivir phosphate capsules
AUC0-inf
Measured: Day1,Day2,Day3,Day5,Day10,Day15,Day20;Conbined period Day1,Day2,Day3,Day6,Day10,Day15,Day20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start28 Aug 2023
- Primary completion5 Dec 2023
- Study completion26 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug InteractionStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Zenshine Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057103
- Sponsor's protocol ID
- ZX-7101A-208
- Acronym
- ZX-7101A-208
- Status last verified
- Oct 2024
- First submitted
- 12 Sep 2023
- Last updated
- 4 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 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Drug-drug Interaction of ZX-7101A Tablets and Oseltamivir Phosphate Capsules in Healthy Adult Subjects -a Single-center, Open-labelled, Six-sequence, Three-cycle Crossover Design
- ClinicalTrials.gov ID
- NCT06057103
- Acronym / sponsor ID
- ZX-7101A-208 / ZX-7101A-208
- Conditions
- Drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Nanjing Zenshine PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 5 Dec 2023 (actual)
- Study completion
- 26 Apr 2024 (actual)
- First posted
- 28 Sep 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 primary object of this study is evaluating the effect of multiple oral oseltamivir phosphate capsules on the pharmacokinetic profile of the active metabolite ZX-7101 after a single oral administration of ZX-7101A tablet in healthy Chinese adult subjects.
The seongdary object is evaluating combined or uncombined multiple oral oseltamivir phosphate in healthy Chinese adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ZX-7101A-1 | Other | Drug: ZX-7101A, Drug: Oseltamivir, Drug: ZX-7101A and Oseltamivir |
| ZX-7101A-2 | Other | Drug: ZX-7101A, Drug: ZX-7101A and Oseltamivir, Drug: Oseltamivir |
| Oseltamivir-1 | Other | Drug: Oseltamivir, Drug: ZX-7101A, Drug: ZX-7101A and Oseltamivir |
| Oseltamivir-2 | Other | Drug: Oseltamivir, Drug: ZX-7101A and Oseltamivir, Drug: ZX-7101A |
| Combined-1 | Other | Drug: ZX-7101A and Oseltamivir, Drug: ZX-7101A, Drug: Oseltamivir |
| Combined-2 | Other | Drug: ZX-7101A and Oseltamivir, Drug: Oseltamivir, Drug: ZX-7101A |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male or female subjects between the ages of 18 and 45 years (including the threshold value, based on the date of signing ICF).
- Weight: Male weight ≥50 kg, female weight ≥45 kg, BMI between 19.0 and 28.0 kg/m2 (including cut-off value), BMI= weight (kg)/height 2 (m2).
- The investigator judged the subjects to be in good overall health based on their medical history, physical examination, vital signs, 12-lead electrocardiogram, laboratory tests (routine blood work, urine work, blood biochemistry, coagulation function), viral serology, and chest X-ray results (normal or abnormal test results have no clinical significance).
- Fertile female subjects or male subjects who voluntarily signed ICF should be no fertile, sperm/egg donation for 6 months (female) or 90 days (male) from the beginning to the last dose, and voluntary use highly effective contraception (including partner) (non-drug contraception is required during the trial).
- Fully understand the trial content and possible adverse reactions, have the ability to communicate with researchers normally, while complying with study requirements, follow protocol procedures and restrictions, and be able to visit on time.
Key exclusion criteria (10 listed)
- Subjects with a prior or present history of clinically abnormal metabolic, liver, kidney, hematological, pulmonary, cardiovascular, gastrointestinal, urinary, endocrine, neurological, or psychiatric disease who were judged by the investigator to be unsuitable for participation in this study.
- Subjects with digestive tract disease or any condition that may affect drug absorption, such as a history of liver and gallbladder disease, gastrointestinal disease, gastrointestinal surgery (except appendectomy) or a history of chronic pancreatitis, idiopathic acute pancreatitis, or habitual diarrhea.
- Allergic constitutions (such as allergies to two or more drugs, foods, and pollen), or determined by the investigator, may be allergic to the investigational product or any component of the investigational product.
- Acute respiratory infections within 2 weeks before screening; Or have a history of fungal infection.
- For patients with abnormal vital signs (blood pressure, pulse rate, ear temperature) and clinically significant results, the abnormal values of each vital sign are:Body temperature (ear temperature) >37.5 ℃; Systolic blood pressure (recumbent) <90 mmHg or ≥140 mmHg; Diastolic blood pressure (lying) <50 mmHg or ≥90 mmHg; Pulse rate (lying position) <50 beats/min or >100 beats/min.
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-7101AZX-7101A Tablets single dose tablet, 80 mg, Oral | Drug | ZX-7101A-1, ZX-7101A-2 |
| OseltamivirOseltamivir phosphate capsule was administered as a single drug, 75 mg twice daily, for 5 days,Oral | Drug | Oseltamivir-1, Oseltamivir-2, ZX-7101A-1 |
| ZX-7101A and OseltamivirZX-7101A tablet (80mg, single dose) was combined with oseltamivir phosphate capsule (75 mg twice daily),Oral | Drug | Combined-1, Combined-2, Oseltamivir-2, ZX-7101A-1, ZX-7101A-2 |
| ZX-7101AZX-7101A Tablets single dose tablet, 80 mg, Oral | Drug | Combined-1, Oseltamivir-1, Oseltamivir-2 |
| OseltamivirOseltamivir phosphate capsule was administered as a single drug, 75 mg twice daily, for 5 days,Oral | Drug | Combined-1, Combined-2, ZX-7101A-2 |
| ZX-7101A and OseltamivirZX-7101A tablet (80mg, single dose) was combined with oseltamivir phosphate capsule (75 mg twice daily),Oral | Drug | Oseltamivir-1 |
| ZX-7101AZX-7101A Tablets single dose tablet, 80 mg, Oral | Drug | Combined-2 |
Primary outcome
PK parameters of active metabolite ZX-7101 in healthy Chinese adult subjects after a single oral ZX-7101A tablet combined with multiple oral oseltamivir phosphate capsules
Time frame: Day1,Day2,Day3,Day5,Day10,Day15,Day20;Conbined period Day1,Day2,Day3,Day6,Day10,Day15,Day20
Cmax
PK parameters of active metabolite ZX-7101 in healthy Chinese adult subjects after a single oral ZX-7101A tablet combined with multiple oral oseltamivir phosphate capsules
Time frame: Day1,Day2,Day3,Day5,Day10,Day15,Day20;Conbined period Day1,Day2,Day3,Day6,Day10,Day15,Day20
AUC0-t
PK parameters of active metabolite ZX-7101 in healthy Chinese adult subjects after a single oral ZX-7101A tablet combined with multiple oral oseltamivir phosphate capsules
Time frame: Day1,Day2,Day3,Day5,Day10,Day15,Day20;Conbined period Day1,Day2,Day3,Day6,Day10,Day15,Day20
AUC0-inf
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 4 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.
The record lists no contact. Use the official record to reach the sponsor.
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, Oseltamivir and ZX-7101A and Oseltamivir in people with Drug Interaction, 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 5 inclusion and 10 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 4 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?
PK parameters of active metabolite ZX-7101 in healthy Chinese adult subjects after a single oral ZX-7101A tablet combined with multiple oral oseltamivir phosphate capsules (time frame: Day1,Day2,Day3,Day5,Day10,Day15,Day20;Conbined period Day1,Day2,Day3,Day6,Day10,Day15,Day20). 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 4 Nov 2024.