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

Sponsor

Sunshine Lake Pharma Co., Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05998304

Collaborator

(none)

Enrollment

Location

Arm

1.7

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Male Subjects	Drug: [14C] Yiqibuvir	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

8 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Aug 10, 2023

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: [14C] Yiqibuvir Eligible healthy male subjects received a single oral 600 mg (radioactivity of 100µCi) dose of [14C] Yiqibuvir	Drug: [14C] Yiqibuvir 600 mg suspension containing 100µCi of [14C] Yiqibuvir

Arm

Intervention/Treatment

Experimental: [14C] Yiqibuvir

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

Drug: [14C] Yiqibuvir

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai xuhui central hospital	Shanghai	Shanghai	China

Sponsors and Collaborators

Sunshine Lake Pharma Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sunshine Lake Pharma Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05998304

Other Study ID Numbers:

HEC110114-HCV-103/CRC-C2314

First Posted:

Aug 18, 2023

Last Update Posted:

Aug 18, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 18, 2023