Single Dose Absorption, Distribution, Metabolism, and Excretion Study of [14C] Yiqibuvir in Healthy Male Participants

HEC110114-HCV-103/CRC-C2314

This is a single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of \[14C\] Yiqibuvir.

2023-08-07

2023-09-12

2023-09-12

Completed

Early phase I

8

Inclusion Criteria: * signing of informed consent * Weight: Body mass index (BMI) is 19.0\~28.0 kg/m2 * Subjects are able to communicate well with the investigators and be able to complete the trial according to the process Exclusion Criteria: * Those who are known to have allergy history or allergy constitution to the test preparation and any of its components or related preparations * Positive test for hepatitis B (surface antigens HBs), or C (antibody HCs), positive test for HIV, Treponema pallidum antibody positive * Positive results from urine drug screen test * Donate blood or lose blood 400 mL or more within 3 month prior to dosing * Subjects who have used any medication, biological product, Chinese patent medicine, herbal medicine, nutritional supplements or health care products within 14 days prior to the first dose of study medication, or participated in other clinical studies or participated in a clinical study of test preparation within 3 months prior to the first dose of study medication * History of needles or blood fainting, or have difficulty in blood collection or cannot tolerate venipuncture for blood collection

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 8, 'type': 'ACTUAL'}}

2024-02-21