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

NCT07080658 | Completed Phase 1

• 1 other identifier: WPV01-MB-01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (8)

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

  Up to 168 hours(approx) from drug administration

• Total radioactivity of WPV01-related substances in human plasma

  Up to 168 hours(approx) from drug administration

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

  Up to 168 hours(approx) from drug administration

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

  Up to 168 hours(approx) from drug administration

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

  Up to 168 hours(approx) from drug administration

• Identification of metabolites in plasma

  Up to 168 hours(approx) from drug administration

• Identification of metabolites in urine

  Up to 168 hours(approx) from drug administration

• Identification of metabolites in feces

  Up to 168 hours(approx) from drug administration

Secondary Outcomes (10)

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

  Up to 168 hours(approx) from drug administration

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

  Up to 168 hours(approx) from drug administration

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

  Up to 168 hours(approx) from drug administration

• Number of Participants With Adverse Events

  At least up to 14 days from drug administration

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

  Up to 168 hours(approx) from drug administration

Study Arms (1)

WPV01

EXPERIMENTAL

Drug: [14C]-WPV01

Interventions

[14C]-WPV01 DRUG

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

WPV01

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Healthy adult males
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Westlake Pharmaceuticals (Hangzhou) Co., Ltd.: lead

Study Sites (1)

Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Wei Zhao

  Qianfoshan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 23, 2025
• Study Start: July 23, 2023
• Primary Completion: July 24, 2023
• Study Completion: August 6, 2023
• Last Updated: July 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)