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COVID-19Phase 1NCT07080658

[14C] Study to Investigate the Mass Balance and Biotransformation of WPV01 in Healthy Adult Chinese Male Participants

A Phase 1 study testing [14C]-WPV01 in people with COVID-19, run by Westlake Pharmaceuticals (Hangzhou) Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single-center, non-randomized, open-label, single-dose, Phase I clinical study to evaluate the mass balance and biotransformation, safety and tolerability of WPV01 in healthy adult chinese male participants following a single oral administration of [14C] WPV01. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
[14C]-WPV01
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
23 Jul 2023to 6 Aug 2023
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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adult males
  • Participants aged ≥18 years and ≤55 years old
  • Body weight: Body mass index (BMI) between 19.0 and 26.0 kg/m2 (including borderline values), body weight no less than 50.0 kg.
  • Voluntarily participate in the clinical trial and sign the informed consent
  • Able to communicate well with the investigator and able to complete the trial in accordance with the protocol

Who cannot join

  • Participants who have abnormalities and clinical significance after comprehensive physical examination, vital signs, routine laboratory tests, thyroid function, chest CT, abdominal ultrasound, etc.
  • Participants whose 12-lead electrocardiogram test results show corrected QT interval ≥450 msec
  • Participants who is positive for Hepatitis B Surface Antigen, Hepatitis C Antibody, HIV Antibody and Syphilis Antibody
  • Participants who have used any drug that inhibits or induces hepatic drug metabolizing enzymes within 30 days prior to the screening period
  • Participants who have used any prescription medication, over-the-counter medication, herbal or dietary supplements, such as vitamins, calcium supplements, within 14 days prior to the screening period
  • Participants who have a history of any clinically serious disease or disease/condition that, in the opinion of the investigator, may affect the results of the test, including, but not limited to, a history of circulatory, respiratory, endocrine, neurological, gastrointestinal, urological, or hematological, immunological, psychiatric, and metabolic disorders
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  • Participants who have any condition that may affect drug absorption, e.g., gastrectomy, cholecystectomy, gastric bypass, duodenotomy, colectomy, history of inflammatory bowel disease
  • Participants who have history of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, ventricular tachycardia, atrioventricular block, QT prolongation syndrome, or symptoms of QT prolongation syndrome, and a family history of the disease (as evidenced by genetic predisposition or by the death of a close family member from a cardiac cause at a young age).
  • Participants who have undergone major surgery within 6 months prior to the screening period or whose surgical incisions have not completely healed; major surgery includes, but is not limited to, any surgery with significant risk of hemorrhage, prolonged general anesthesia, or incisional biopsy or significant traumatic injury
  • Participants who have specific allergic history, such as those with a known history of allergy to two or more substances; or those who, in the judgment of the investigator, may be allergic to the test drug or its excipients
  • Participants who have perianal disease with regular/ongoing blood in stool, irritable bowel syndrome, inflammatory bowel disease
  • Participants who have habitual constipation or diarrhea
  • Participants who are alcohol abusers or regularly drink alcohol in the 6 months prior to the screening period, i.e., more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits at 40% alcohol by volume or 150 mL of wine); or an alcohol breath test result of >0 mg/dL at the time of the screening period
  • Participants who smoked >5 cigarettes per day in the 3 months prior to the screening period or habitually used nicotine-containing products and were unable to quit during the trial period
  • Participants who are substance abusers or use soft drugs (e.g., marijuana) in the 3 months prior to the screening period or use of hard drugs (e.g., cocaine, amphetamines, phenylcyclohexylpiperidine, etc.) in the 1 year prior to the screening period; or a positive urine drug test at the screening period
  • Participants who consume grapefruit juice or excessive amounts of tea, coffee and/or caffeinated beverages that cannot be stopped during the trial period
  • Participants who are exposed to radiation for prolonged periods of time; or who have had significant radiation exposure (≥2 chest/abdominal CTs, or ≥3 other types of X-rays) or participated in radiopharmaceutical labeling tests within 1 year prior to testing
  • Participants who are with a history of needle and blood sickness, those who have difficulty in blood collection or cannot tolerate venipuncture blood collection
  • Participation in any other clinical trial (including clinical trials such as drugs and devices) within 3 months prior to the screening period
  • Participants who have vaccinated within 1 month prior to screening or scheduled to be vaccinated during the trial period
  • Participants who plan to have children or donate sperm during the trial and within 1 year after completion of the trial, or who do not agree that the subject and his/her spouse should use strict contraception during the trial and within 1 year after completion of the trial
  • Participants who have had blood loss or donated up to 400 mL of blood within 3 months prior to the screening period, or those who have received a blood transfusion within 1 month
  • Participants who, in the opinion of the investigator, have any factors that make participation in this trial inappropriate

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shandong Provincial Qianfoshan Hospital

    Jinan, Shandong

Other trials in China

About this study

Official title: A Phase I Study to Investigate The Mass Balance and Biotransformation of WPV01 in Healthy Adult Chinese Male Participants

This is a single-center, non-randomized, open-label, single-dose, Phase I clinical study to evaluate the mass balance and biotransformation, safety and tolerability of WPV01 in healthy adult chinese male participants following a single oral administration of [14C] WPV01.

Read the detailed description

This trial is planned to enroll 6-8 healthy Chinese male subjects. Each subject is administered a single oral dose containing 600 mg/approximately 100 µCi [14C]WPV01 suspension on the first day of the trial in fasting condition.

Whole blood, plasma, urine and fecal samples are collected at defined time points/periods during the test. The whole blood/plasma partition ratio, pharmacokinetic parameters of total radioactivity in plasma, recovery and excretion pathway data of [14C]WPV01 are calculated by measuring the total radioactivity. The major metabolic elimination pathways and characterization of WPV01 in the human body, as well as circulating metabolites that are close to or above 10% of total plasma radioactivity exposure, are obaitned from structural characterization of plasma, urine and fecal radio-metabolite profiles and major metabolites.

All excreted urine and fecal samples are collected at specified time intervals from 0 to 336h post-dose and and blood samples are collected at specified time points from 0 to 144h post-dose.

Conditions
COVID-19
Being tested
[14C]-WPV01
Medical subject headings
COVID-19

What participants receive

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

  • [14C]-WPV01Drug

    Single oral dose of 600 mg [14C]-WPV01

Study groups in NCT07080658
Study groupRoleWhat they receive
WPV01ExperimentalNot described
Receives: Drug: [14C]-WPV01

What is being measured

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

  1. Total recovery and cumulative recovery of total WPV01-related radioactive material in excreta (urine and feces)

    Measured: Up to 168 hours(approx) from drug administration

  2. Total radioactivity of WPV01-related substances in human plasma

    Measured: Up to 168 hours(approx) from drug administration

  3. Ratio of total WPV01-related radioactivity concentrations in human whole blood and plasma at different time points

    Measured: Up to 168 hours(approx) from drug administration

  4. WPV01 and its metabolites in human plasma as a percentage of total plasma radioactivity exposure

    Measured: Up to 168 hours(approx) from drug administration

  5. WPV01 and its metabolites in human excreta (urine and feces) as a percentage of total urine/feces radioactivity exposure

    Measured: Up to 168 hours(approx) from drug administration

  6. Identification of metabolites in plasma

    Measured: Up to 168 hours(approx) from drug administration

  7. Identification of metabolites in urine

    Measured: Up to 168 hours(approx) from drug administration

  8. Identification of metabolites in feces

    Measured: Up to 168 hours(approx) from drug administration

Secondary outcomes (10)

  1. Time to maximum plasma concentration of WPV01 and its metabolites (if applicable) in plasma

    Measured: Up to 168 hours(approx) from drug administration

  2. Maximum plasma concentration of WPV01 and its metabolites (if applicable) in plasma

    Measured: Up to 168 hours(approx) from drug administration

  3. Terminal half-life of WPV01 and its metabolites (if applicable) in plasma

    Measured: Up to 168 hours(approx) from drug administration

  4. Number of Participants With Adverse Events

    Measured: At least up to 14 days from drug administration

  5. Area under the plasma concentration-time curve of WPV01 and its metabolites (if applicable) in plasma

    Measured: Up to 168 hours(approx) from drug administration

  6. Mean residence time of WPV01 and its metabolites (if applicable) in plasma

    Measured: Up to 168 hours(approx) from drug administration

  7. Number of Participants With Clinically Notable Vital Signs

    Measured: At least up to 14 days from drug administration

  8. Number of Participants With Clinically Notable Laboratory Tests

    Measured: At least up to 14 days from drug administration

  9. Number of Participants With Clinically Notable ECG Tests

    Measured: At least up to 14 days from drug administration

  10. Number of Participants With Clinically Notable Physical Examination

    Measured: At least up to 14 days from drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2025
  2. Study start23 Jul 2023
  3. Primary completion24 Jul 2023
  4. Study completion6 Aug 2023

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07080658
Sponsor's protocol ID
WPV01-MB-01
Status last verified
Apr 2025
First submitted
12 Jul 2024
Last updated
23 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]-WPV01 in people with COVID-19, run by Westlake Pharmaceuticals (Hangzhou) 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 23 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 23 Jul 2025. 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?

Total recovery and cumulative recovery of total WPV01-related radioactive material in excreta (urine and feces) (time frame: Up to 168 hours(approx) from drug administration). The study lists 8 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 NCT07080658.

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 23 Jul 2025.

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