HealthyPhase 1NCT05716126
Single Dose Mass Balance Study With [14C]Iruplinalkib (WX-0593) In Healthy Male Volunteers
A Phase 1 study testing [14C]Iruplinalkib (WX-0593) in people with Healthy, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- [14C]Iruplinalkib (WX-0593)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2020to 13 Jan 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- [14C]Iruplinalkib (WX-0593)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]Iruplinalkib (WX-0593)Drug
Volunteer will receive a single oral dose of 120 mg [14C]Iruplinalkib (WX-0593) as a solution on Day 1
| Study group | Role | What they receive |
|---|---|---|
| [14]Iruplinalkib(WX-0593) 120 mg(orla solution) | Experimental | Volunteer will receive a single oral dose of 120 mg [14C]Iruplinalkib (WX-0593) administered by mouth, as a solution. Receives: Drug: [14C]Iruplinalkib (WX-0593) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic profiling for iruplinalkib(WX-0593) will be determined in plasma samples.
Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces.
Measured: Assessments will be made up to 3 days post dose.
Metabolic profiling for iruplinalkib(WX-0593) will be determined in urine samples.
Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in urine.
Measured: Assessments will be made up to 3 days post dose.
metabolic profiling for iruplinalkib(WX-0593) will be determined in fecal samples.
Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in feces.
Measured: Assessments will be made up to 3 days post dose.
Total Radioactivity in Feces
Cumulative amount was calculated as sum of feces drug concentration in sample volume for each collection interval.
Measured: Assessments will be made up to 14 days post dose.
Total Radioactivity in Urine
Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval.
Measured: Assessments will be made up to 14 days post dose.
Secondary outcomes (1)
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Measured: Assessments will be made up to 28 days post dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start15 Apr 2020
- Primary completion15 Dec 2020
- Study completion13 Jan 2021
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 Qilu Pharmaceutical 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716126
- Sponsor's protocol ID
- WX0593-005
- Status last verified
- Feb 2023
- First submitted
- 27 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluating the Mass Balance and Biotransformation of Single Dose [14C]Iruplinalkib (WX-0593) In Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT05716126
- Acronym / sponsor ID
- WX0593-005
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 13 Jan 2021 (actual)
- First posted
- 8 Feb 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14]Iruplinalkib(WX-0593) 120 mg(orla solution) | Experimental | Drug: [14C]Iruplinalkib (WX-0593)Volunteer will receive a single oral dose of 120 mg [14C]Iruplinalkib (WX-0593) administered by mouth, as a solution. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (19 listed)
- 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;
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 |
|---|---|---|
| [14C]Iruplinalkib (WX-0593)Volunteer will receive a single oral dose of 120 mg [14C]Iruplinalkib (WX-0593) as a solution on Day 1 | Drug | [14]Iruplinalkib(WX-0593) 120 mg(orla solution) |
Primary outcome
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.
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.
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.
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.
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.
1 secondary outcome
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Time frame: Assessments will be made up to 28 days post dose.
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 8 Feb 2023.
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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 [14C]Iruplinalkib (WX-0593) in people with Healthy, run by Qilu Pharmaceutical 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 3 inclusion and 19 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 8 Feb 2023. 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?
Metabolic profiling for iruplinalkib(WX-0593) will be determined in plasma samples. (time frame: Assessments will be made up to 3 days post dose.). The study lists 5 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 8 Feb 2023.