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

Phase 1

Completed

• Conditions: Healthy Male Subjects
• Interventions: Drug: [14C] Yiqibuvir

• Registration Number: NCT05998304
• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-26
• Study Start: 2023-08-07
• Study First Submitted QC: 2023-08-16
• Study First Posted: 2023-08-18
• Primary Completion: 2023-09-12
• Study Completion: 2023-09-12
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[14C] Yiqibuvir	[14C] Yiqibuvir	Eligible healthy male subjects received a single oral 600 mg (radioactivity of 100µCi) dose of \[14C\] Yiqibuvir

Primary Outcome Measures

Name	Time	Method
Cumulative excretion of [14C] Yiqibuvir -related material (radioactivity in plasma, urine and fecal samples)	up to 18 days	Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces.

Secondary Outcome Measures

Name	Time	Method
Identification of the Proportion of different metabolites to determine biotransformation pathway of Yiqibuvir	up to 18 days	Proportion of different metabolites(Yiqibuvir and main metabolites）
Quantitive analysis of the concentrations of Yiqibuvir and main metabolites in plasma using the validated LC-MS/MS to obtain pharmacokinetic data	up to 18 days	The concentrations of Yiqibuvir and main metabolites in plasma
Number of adverse events (AE) experienced by subjects	up to 18 days	To examine the safety and tolerability of \[14C\] Yiqibuvir given orally

Trial Locations

Locations (1)

Shanghai xuhui central hospital; 🇨🇳 Shanghai, Shanghai, China