ADME Study of [14C] Yiqibuvir in Healthy Male Subjects

Sunshine Lake Pharma Co., Ltd.8 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy Male Subjects

Interventions

[14C] YiqibuvirDRUG

600 mg suspension containing 100µCi of \[14C\] Yiqibuvir

Eligibility

Sex: MALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Shanghai xuhui central hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Cumulative excretion of [14C] Yiqibuvir -related material (radioactivity in plasma, urine and fecal samples)

Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces.

Time frame: up to 18 days

Secondary Outcomes

Identification of the Proportion of different metabolites to determine biotransformation pathway of Yiqibuvir

Proportion of different metabolites(Yiqibuvir and main metabolites）

Time frame: up to 18 days

Quantitive analysis of the concentrations of Yiqibuvir and main metabolites in plasma using the validated LC-MS/MS to obtain pharmacokinetic data

The concentrations of Yiqibuvir and main metabolites in plasma

Time frame: up to 18 days

Number of adverse events (AE) experienced by subjects

To examine the safety and tolerability of \[14C\] Yiqibuvir given orally

Time frame: up to 18 days

Data from ClinicalTrials.gov

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