A Clinical Trial of XZP-3287 for Material Balance

July 25, 2022 updated by: Xuanzhu Biopharmaceutical Co., Ltd.

the Material Balance and Biotransformation Study of [14C] XZP-3287 in Healthy Chinese Male Subjects

A single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of [14C] XZP-3287

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100070

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Healthy adult males aged 18 to 45 years (inclusive).
  2. Body weight ≥ 50 kg for males; body mass index (BMI) in the range 19-26 kg/m2 (inclusive).
  3. No mental disorders, cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system and metabolic abnormalities.
  4. No clinically significant vital signs, physical examination, laboratory tests, ECG findings.
  5. No plans to have children within the last 12 months, and willing to use effective contraception within 12 months after the end of dosing.
  6. Subjects are able to communicate well with the investigators, and be able to complete the trial according to the process, and sign an Informed Consent Form.

Exclusion Criteria:

  1. Subjects with a history of drug allergy, or atopic allergic disease (Asthma, urticaria, eczema dermatitis), or a known history of allergy to the test drug or its adjuvant components.
  2. History of clinically significant ECG abnormalities or family history of long QT syndrome.
  3. History of any significantly diseases affect drug absorption, distribution, metabolism, and excretion.
  4. Positive test for hepatitis B (surface antigens HBs), or C (antibody HCs), positive test for HIV, Treponema pallidum antibody positive.
  5. Positive results from urine drug screen test.
  6. Donate blood or lose blood 200 mL or more within 1 month prior to dosing.
  7. Subjects who have used any medication, herbal medicine, nutritional supplements or health care products within 4 weeks prior to the first dose of study medication, or participated in other clinical studies or participated in a clinical study of test preparation within 3 months prior to the first dose of study medication.
  8. History of needles or blood fainting, or have difficulty in blood collection, or cannot tolerate venipuncture for blood collection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: [14C]XZP-3287
Eligible healthy male subjects received a single oral 360 mg (radioactivity of 50µCi) dose of [14C]XZP-3287
Drug: [14C]XZP-3287
360 mg suspension containing 50µCi of [14C] XZP-3287

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PK data for 14C-XZP-3287: Cmax
Time Frame: up to 15 days
Maximum observed concentration for XZP-3287 in plasma and whole blood total radioactivity
up to 15 days
PK data for 14C-XZP-3287: AUClast
Time Frame: up to 15 days
Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration for XZP-3287 in plasma and whole blood total radioactivity
up to 15 days
PK data for 14C-XZP-3287: AUCinf
Time Frame: up to 15 days
Area under the plasma concentration time profile from time 0 to infinity for XZP-3287 in plasma and whole blood total radioactivity
up to 15 days
PK data for 14C-XZP-3287: Tmax
Time Frame: up to 15 days
Time of maximum observed concentration for XZP-3287 in plasma and whole blood total radioactivity
up to 15 days
Quantitative analysis of cumulative excretion and excretion rate in excreta (urine and faeces)
Time Frame: up to 15 days
Quantitative analysis of total radioactivity in excreta after oral [14C]XZP-3287 in healthy subjects, obtaining body material balance data and main excretion pathways
up to 15 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cmax of XZP-3287 in plasma
Time Frame: up to 15 days
Maximum observed concentration for XZP-3287 in plasma
up to 15 days
AUClast of XZP-3287 in plasma
Time Frame: up to 15 days
Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration for XZP-3287 in plasma
up to 15 days
AUCinf of XZP-3287 in plasma
Time Frame: up to 15 days
Area under the plasma concentration time profile from time 0 to infinity for XZP-3287 in plasma
up to 15 days
Tmax of XZP-3287 in plasma
Time Frame: up to 15 days
Time of maximum observed concentration for XZP-3287 in plasma
up to 15 days
To evaluate the safety of [14C] XZP-3287
Time Frame: up to 29 days
Percentage of Participants with Adverse Events (AEs)
up to 29 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xuanzhu Biopharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 2, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 4, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 4, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XZP-3287-1004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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