HealthyPhase 1NCT04951713
Effect of Clarithromycin and Rifampicin on the Pharmacokinetics of XZP-3287 in Healthy Subjects
A Phase 1 study testing XZP-3287 combined with clarithromycin and XZP-3287 combined with rifampicin in people with Healthy, run by Xuanzhu Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a phase I study to assess the drug-drug interaction of XZP-3287 and Clarithromycin/Rifampicin. The study also evaluates the pharmacokinetic and tolerability of XZP-3287 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- XZP-3287 combined with clarithromycin and XZP-3287 combined with rifampicin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jul 2021to Dec 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female subjects aged 18 to 65 years (including 18 and 65);
- Male body weight ≥50kg, female body weight ≥45kg, body mass index between 18 to 28 kg/m2 (inclusive).
- No medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.
- Subjects shall ake effective contraceptive measures voluntarily within 3 months from the date of signing the informed consent form (for women, 2 weeks before trial screening) to the date of the last medication.
- Willing and able to comply with all scheduled visits, study procedures, and provides written informed consent
Who cannot join
- Allergic constitution and those with known allergy to XZP-3287 or similar drugs and excipients
- Abnormal clinical tests and clinical significance judged by the investigator
- Frequent use of sedatives, sleeping pills or other addictive drugs within 6 months before enrollment
- History of drug use, or drug abuse screening positive
- Those who had smoked more than 5 cigarettes per day on average in the 3 months before the screening period or habitually used nicotine-containing products and were unable to quit during the test period
- Heavy drinking or regular drinking in the six months preceding the screening period
Show all 18Show fewer
- Use of any prescription drug or Chinese herbal medicine within 4 weeks prior to enrollment, or use of any over-the-counter drug, any vitamin product, health care drug within 14 days prior to enrollment;
- Treatment with an investigational drug within 3 months
- Participated in blood donation with blood donation volume ≥400 mL or received blood transfusion within 3 months before screening.
- Had a severe infection, trauma or major surgery within 4 weeks of screening
- Gastrointestinal disorders causing clinically significant symptoms such as nausea, vomiting, and diarrhea, or malabsorption syndromes
- Pregnant or lactating women, or subjects cannot take strict contraceptive measures as required.
- Hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV antibody and syphilis antibody, any of which are positive.
- Allergic to any food ingredients or has special requirements on diet, cannot follow the unified diet
- habitual consumption of food or beverage containing methylxanthine, such as tea, coffee, cola, chocolate and so on during the study period
- habitual consumption of grapefruit juice during the study period
- have difficulty in blood collection or cannot tolerate vein puncture for blood collection
- As determined by the investigator, the subject has other factors that are not suitable for the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui
Huan Zhou, 0086-0522-3086943, zhouhuanbest@vip.163.com
About this study
Official title: A Single-center, Open-label, Drug-drug Interaction Study of XZP-3287 Tablets in Healthy Subjects
This is a phase I study to assess the drug-drug interaction of XZP-3287 and Clarithromycin/Rifampicin. The study also evaluates the pharmacokinetic and tolerability of XZP-3287 in healthy subjects.
- Conditions
- Healthy
- Being tested
- XZP-3287 combined with clarithromycin, XZP-3287 combined with rifampicin
- Keywords
- XZP-3287, drug-drug interaction, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XZP-3287 combined with clarithromycinDrug
Drug: XZP-3287, oral, 120 mg once daily for day 1 and day 12 Drug: clarithromycin, oral, 500 mg twice daily for day 8 to day 21
XZP-3287 combined with rifampicinDrug
Drug: XZP-3287, oral, 360 mg once daily for day 1 and day 14 Drug: rifampicin, oral, 600 mg once daily for day 8 to day 19
| Study group | Role | What they receive |
|---|---|---|
| XZP-3287 combined with clarithromycin | Experimental | XZP-3287 combined with clarithromycin Receives: Drug: XZP-3287 combined with clarithromycin |
| XZP-3287 combined with rifampicin | Experimental | XZP-3287 combined with rifampicin Receives: Drug: XZP-3287 combined with rifampicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary PK Endpoints
Cmax
Measured: day 1~day 20/day22
Primary PK Endpoints
AUC0-∞
Measured: day 1~day 20/day22
Primary PK Endpoints
AUC0-t
Measured: day 1~day 20/day22
Secondary outcomes (5)
Secondary PK measures
Tmax
Measured: day 1~day 20/day22
Secondary PK measures
T1/2
Measured: day 1~day 20/day22
Secondary PK measures
CL/F
Measured: day 1~day 20/day22
Secondary PK measures
Vz/F
Measured: day 1~day 20/day22
SAFETY/TOLERABILITY
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE 5.0
Measured: Up to 10 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study startJul 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Xuanzhu Biopharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04951713
- Sponsor's protocol ID
- XZP-3287-1003
- Status last verified
- Jun 2021
- First submitted
- 16 Jun 2021
- Last updated
- 27 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Drug-drug Interaction Study of XZP-3287 Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04951713
- Acronym / sponsor ID
- XZP-3287-1003
- Conditions
- Healthy
- Keywords
- XZP-3287, drug-drug interaction, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 7 Jul 2021 (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.
This is a phase I study to assess the drug-drug interaction of XZP-3287 and Clarithromycin/Rifampicin. The study also evaluates the pharmacokinetic and tolerability of XZP-3287 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XZP-3287 combined with clarithromycin | Experimental | Drug: XZP-3287 combined with clarithromycinXZP-3287 combined with clarithromycin |
| XZP-3287 combined with rifampicin | Experimental | Drug: XZP-3287 combined with rifampicinXZP-3287 combined with rifampicin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy male or female subjects aged 18 to 65 years (including 18 and 65);
- Male body weight ≥50kg, female body weight ≥45kg, body mass index between 18 to 28 kg/m2 (inclusive).
- No medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.
- Subjects shall ake effective contraceptive measures voluntarily within 3 months from the date of signing the informed consent form (for women, 2 weeks before trial screening) to the date of the last medication.
- Willing and able to comply with all scheduled visits, study procedures, and provides written informed consent
Key exclusion criteria (18 listed)
- Allergic constitution and those with known allergy to XZP-3287 or similar drugs and excipients
- Abnormal clinical tests and clinical significance judged by the investigator
- Frequent use of sedatives, sleeping pills or other addictive drugs within 6 months before enrollment
- History of drug use, or drug abuse screening positive
- Those who had smoked more than 5 cigarettes per day on average in the 3 months before the screening period or habitually used nicotine-containing products and were unable to quit during the test period
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 |
|---|---|---|
| XZP-3287 combined with clarithromycinDrug: XZP-3287, oral, 120 mg once daily for day 1 and day 12 Drug: clarithromycin, oral, 500 mg twice daily for day 8 to day 21 | Drug | XZP-3287 combined with clarithromycin |
| XZP-3287 combined with rifampicinDrug: XZP-3287, oral, 360 mg once daily for day 1 and day 14 Drug: rifampicin, oral, 600 mg once daily for day 8 to day 19 | Drug | XZP-3287 combined with rifampicin |
Primary outcome
Primary PK Endpoints
Time frame: day 1~day 20/day22
Cmax
Primary PK Endpoints
Time frame: day 1~day 20/day22
AUC0-∞
Primary PK Endpoints
Time frame: day 1~day 20/day22
AUC0-t
5 secondary outcomes
Secondary PK measures
Time frame: day 1~day 20/day22
Secondary PK measures
Time frame: day 1~day 20/day22
Secondary PK measures
Time frame: day 1~day 20/day22
Secondary PK measures
Time frame: day 1~day 20/day22
SAFETY/TOLERABILITY
Time frame: Up to 10 days after last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
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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.
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 XZP-3287 combined with clarithromycin and XZP-3287 combined with rifampicin in people with Healthy, run by Xuanzhu Biopharmaceutical 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 5 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 27 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhimin Zhou (0086-13647211506, zhouzhimin@xuanzhubio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary PK Endpoints (time frame: day 1~day 20/day22). 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 27 Jul 2021.