Trials Sponsors Conditions Drugs Pricing

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
+5 more secondary outcomes

Study Arms (1)

WPV01

EXPERIMENTAL

Drug: [14C]-WPV01

Interventions

[14C]-WPV01Drug

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

WPV01

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 55 Years

Sexall(Gender-based eligibility)

Gender Eligibility DetailsHealthy adult males

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy adult males
Participants aged ≥18 years and ≤55 years old

Sponsors & Collaborators

Westlake Pharmaceuticals (Hangzhou) Co., Ltd.
Industrylead

Study Sites (1)

Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, China

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

Wei Zhao
Qianfoshan Hospital
PRINCIPAL INVESTIGATOR

Enrollment

6 participants (actual enrollment reported by the registry).

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

Actual (reported)

Primary Completion

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
+8 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (8)

Secondary Outcomes (10)

Study Arms (1)

WPV01

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (8)

Secondary Outcomes (10)

Study Arms (1)

WPV01

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations