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HealthyPhase 1NCT04951765

Effect of Food on the Pharmacokinetics of XZP-3287 in Healthy Subjects

A Phase 1 study testing XZP-3287 in people with Healthy, run by Xuanzhu Biopharmaceutical Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study will be a randomized 3-treatment, cross-over study to evaluate the bioavailability of XZP-3287 administered after a high or low-fat meal. 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
Aug 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.

Cuilan Xiao contact

0086-13699167610

xiaocuilan@xuanzhubio.com

China1 site, 1 recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong

    Yu Cao, 0086-0532-82911767, Caoyu1767@126.com

    Recruiting

Other trials in China

About this study

Official title: A Phase I Study to Examine the Effects of Low and High-fat Meals on Orally Administered XZP-3287 in Healthy Adult Subjects

This study will be a randomized 3-treatment, cross-over study to evaluate the bioavailability of XZP-3287 administered after a high or low-fat meal.

Conditions
Healthy
Being tested
XZP-3287
Keywords
XZP-3287, Food Effect, Pharmacokinetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XZP-3287Drug

    Cycle1 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle2 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast

  • XZP-3287Drug

    Cycle1 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle2 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 before starting a low-fat breakfast

  • XZP-3287Drug

    Cycle1 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle2 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast

  • XZP-3287Drug

    Cycle1 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle2 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast

  • XZP-3287Drug

    Cycle1 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle2 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast

  • XZP-3287Drug

    Cycle1 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle2 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle3 Day 1: one dose of XZP-3287 before starting a low-fat breakfast

Study groups in NCT04951765
Study groupRoleWhat they receive
Arm AExperimentalCycle1 Day 1：fasting；Cycle2 Day 1：high-fat meal；Cycle3 Day 1：low-fat meal
Receives: Drug: XZP-3287
Arm BExperimentalCycle1 Day 1：high-fat meal；Cycle2 Day 1：low-fat meal；Cycle3 Day 1：fasting
Receives: Drug: XZP-3287
Arm CExperimentalCycle1 Day 1：low-fat meal；Cycle2 Day 1：fasting；Cycle3 Day 1：high-fat meal
Receives: Drug: XZP-3287
Arm DExperimentalCycle1 Day 1：fasting；Cycle2 Day 1：low-fat meal；Cycle3 Day 1：high-fat meal
Receives: Drug: XZP-3287
Arm EExperimentalCycle1 Day 1：high-fat meal；Cycle2 Day 1：fasting；Cycle3 Day 1：low-fat meal
Receives: Drug: XZP-3287
Arm FExperimentalCycle1 Day 1：low-fat meal；Cycle2 Day 1：high-fat meal；Cycle3 Day 1：fasting
Receives: Drug: XZP-3287

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary PK Endpoints

    Cmax

    Measured: day 1~day 21

  2. Primary PK Endpoints

    AUC0-∞

    Measured: day 1~day 21

  3. Primary PK Endpoints

    AUC0-t

    Measured: day 1~day 21

Secondary outcomes (5)

  1. Secondary PK measures

    Tmax

    Measured: day 1~day 21

  2. Secondary PK measures

    T1/2

    Measured: day 1~day 21

  3. Secondary PK measures

    CL/F

    Measured: day 1~day 21

  4. Secondary PK measures

    Vz/F

    Measured: day 1~day 21

  5. Safety and tolerability

    Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE 5.0

    Measured: Up to 14 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.

  1. First posted7 Jul 2021
  2. Study startAug 2021 (estimated)
  3. Primary completionAug 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

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
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04951765
Sponsor's protocol ID
XZP-3287-1002
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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing XZP-3287 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 Cuilan Xiao (0086-13699167610, xiaocuilan@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 21). 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?

On the ClinicalTrials.gov record for NCT04951765.

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.

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