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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05998304
Other study ID # HEC110114-HCV-103/CRC-C2314
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date August 7, 2023
Est. completion date September 12, 2023

Study information

Verified date July 2023
Source Sunshine Lake Pharma Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date September 12, 2023
Est. primary completion date September 12, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Shanghai xuhui central hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Sunshine Lake Pharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. up to 18 days
Secondary Identification of the Proportion of different metabolites to determine biotransformation pathway of Yiqibuvir Proportion of different metabolites(Yiqibuvir and main metabolites) up to 18 days
Secondary 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 up to 18 days
Secondary Number of adverse events (AE) experienced by subjects To examine the safety and tolerability of [14C] Yiqibuvir given orally up to 18 days
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