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

Westlake Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

COVID-19

Treatments

Drug: [14C]-WPV01

Study type

Interventional

Funder types

Industry

Identifiers

NCT07080658

WPV01-MB-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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
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