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

NCT ID: NCT05998304

Last Updated: 2024-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-07

Study Completion Date

2023-09-12

Brief Summary

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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

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Conditions

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Healthy Male Subjects

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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[14C] Yiqibuvir

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

Group Type EXPERIMENTAL

[14C] Yiqibuvir

Intervention Type DRUG

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

Interventions

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[14C] Yiqibuvir

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sunshine Lake Pharma Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai xuhui central hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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HEC110114-HCV-103/CRC-C2314

Identifier Type: -

Identifier Source: org_study_id

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