Single Dose Mass Balance Study With [14C]Iruplinalkib (WX-0593) In Healthy Male Volunteers

February 5, 2023 updated by: Qilu Pharmaceutical Co., Ltd.

Study Evaluating the Mass Balance and Biotransformation of Single Dose [14C]Iruplinalkib (WX-0593) In Healthy Male Volunteers

This is an open-label, single dose, mass balance and biotransformation study conducted at 1 study center in China. This study will evaluate the absorption, distribution, metabolism, and elimination (ADME), mass balance, safety, and tolerability of a single dose of intravenously administered [14C]Iruplinalkib (WX-0593) in Chinese healthy male volunteers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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 (Actual)

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.
6

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 Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • The First Affiliated Hospital of Soochow University

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

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 18-45 years old (inclusive) healthy male volunteers;
  • Body mass index 19.0-26.0 kg/m 2 (inclusive) and body weight ≥50 kg;
  • The volunteer has fully given informed consent to the study and voluntarily signed the informed consent form prior to trial.

Exclusion Criteria:

  • Physical examination, vital signs, laboratory tests (routine blood test, urinalysis, stool + occult blood test, blood biochemistry, blood coagulation, and thyroid function), ophthalmic examination (slit lamp exam, intraocular pressure, and fundus imaging), 12-lead electrocardiogram, chest X-ray (posteroanterior view), and abdominal ultrasound results that are determined abnormal and clinically significant by the investigator during screening;
  • Positive for HBsAg, HBeAg, HCV antibody, HIV antibody, or syphilis antibody;
  • Has taken any prescribed medication and herbal medicine within 1 month prior to dosing, or has taken over-the-counter medications or food supplements (e.g. Vitamins or calcium) within 2 months prior to dosing;
  • Has participated in clinical trials of any other drug within 3 months prior to dosing;
  • Previous heart disease or family history of heart disease, such as organic heart disease, heart failure, myocardial infarction, angina, irreducible arrhythmia, torsades de pointes, ventricular tachycardia, or long QT syndrome;
  • Major surgery within 6 months prior to dosing or surgical incision is not completely healed; Major surgery includes but is not limited to surgery with any significant risk of bleeding, prolonged general anesthesia, biopsy or significant traumatic injury;
  • Any history of severe clinical illness or disease and conditions that are judged by the investigator to potentially affect the results of the study or disease and history of disease that can reduce treatment adherence (including but not limited to cardiovascular, liver, kidney, gastrointestinal, immune, urinary, blood, endocrine, metabolic, mental, and neurological diseases as well as cancer), especially a history of dysphagia, gastrointestinal ulcers or any gastrointestinal disorders that affect drug absorption;
  • Known allergy to two or more substances; Or potential allergy to the test drug or its excipients in the judgment of the investigator, or allergy to any food ingredients, or special requirements for diet and inability to consume a uniform diet;
  • Hemorrhoids or perianal disease with regular/current bleeding;
  • Habitual constipation, diarrhea, irritable bowel syndrome, or inflammatory bowel disease;
  • Consumed over 14 units of alcohol (1 unit = 360 mL beer or 45 mL of liquor with 40% alcohol or 150 mL wine) weekly within 6 months prior to screening or breath alcohol test result of ≥20 mg/dL;
  • Consumed more than 5 cigarettes daily within 3 months prior to screening or inability to quit smoking during the study;
  • Consumed soft drugs (e.g. Marijuana, MDMA, ketamine or magu/yaba) within 3 months prior to dosing or hard drugs (E.g. Cocaine, heroin, or methamphetamine) within 1 year prior to dosing or positive for urine drug test;
  • Habitually consumed grapefruit or grapefruit juice, or excessively consumed tea, coffee, alcohol and/or drinks containing caffeine or alcohol and unable to quit during hospitalization, or frequent strenuous exercise and other factors that affect drug absorption, distribution, metabolism, and excretion;
  • Consumed any food or drink rich in xanthine (e.g. Animal organs, chocolate, tea, coffee or coke) within 48 hr prior to dosing, or any grapefruit or products containing grapefruit within 48 hr prior to dosing;
  • Donated blood within 3 months prior to dosing or lost >400 mL of blood or received blood transfusion within 8 weeks prior to dosing;
  • Plan to conceive during and within 1 year after trial completion, or disagree with taking strict contraceptive measures (by the volunteer and his spouse) during and within 1 year after trial completion;
  • Work in conditions with long-term radiation exposure, or had significant radiation exposure (received ≥2 chest/abdominal CT, or ≥3 other x-ray exams) within 1 year of signing the informed consent, or participated in radioactive drug trials, or plan to have radiation exposure within 1 year after trial completion.
  • Any other factors which in the judgment of the investigator render the volunteer unsuitable for the trial.

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: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

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: [14]Iruplinalkib(WX-0593) 120 mg(orla solution)
Volunteer will receive a single oral dose of 120 mg [14C]Iruplinalkib (WX-0593) administered by mouth, as a solution.
Drug: [14C]Iruplinalkib (WX-0593)
Volunteer will receive a single oral dose of 120 mg [14C]Iruplinalkib (WX-0593) as a solution on Day 1

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
Metabolic profiling for iruplinalkib(WX-0593) will be determined in plasma samples.
Time Frame: Assessments will be made up to 3 days post dose.
Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces.
Assessments will be made up to 3 days post dose.
Metabolic profiling for iruplinalkib(WX-0593) will be determined in urine samples.
Time Frame: Assessments will be made up to 3 days post dose.
Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in urine.
Assessments will be made up to 3 days post dose.
metabolic profiling for iruplinalkib(WX-0593) will be determined in fecal samples.
Time Frame: Assessments will be made up to 3 days post dose.
Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in feces.
Assessments will be made up to 3 days post dose.
Total Radioactivity in Feces
Time Frame: Assessments will be made up to 14 days post dose.
Cumulative amount was calculated as sum of feces drug concentration in sample volume for each collection interval.
Assessments will be made up to 14 days post dose.
Total Radioactivity in Urine
Time Frame: Assessments will be made up to 14 days post dose.
Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval.
Assessments will be made up to 14 days post dose.

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
Time Frame
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Time Frame: Assessments will be made up to 28 days post dose.
Assessments will be made up to 28 days post dose.

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.
Qilu Pharmaceutical 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 (ACTUAL)

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.
April 15, 2020

Primary Completion (ACTUAL)

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.
December 15, 2020

Study Completion (ACTUAL)

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 13, 2021

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).
January 27, 2023

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.
February 5, 2023

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.
February 8, 2023

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.
February 8, 2023

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.
February 5, 2023

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.
February 1, 2023

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.
  • WX0593-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings