ADME Study of [14C] Antaitavir Hasophate in Healthy Male Subjects

Phase 1

Completed

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

• Registration Number: NCT05446233
• 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 \[14C\] Antaitavir Hasophate.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-01
• Study First Submitted QC: 2022-07-01
• Study First Posted: 2022-07-06
• Status Verified: 2022-11
• Study Start: 2022-11-15
• Primary Completion: 2023-01-02
• Study Completion: 2023-01-02
• Last Update Submitted: 2023-01-04
• Last Update Posted: 2023-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[14C] Antaitavir Hasophate	[14C] Antaitavir Hasophate	Eligible healthy male subjects received a single oral 100 mg (radioactivity of 200µCi) dose of \[14C\] Antaitavir Hasophate

Primary Outcome Measures

Name	Time	Method
Distribution ratio of total radioactivity in whole blood and plasma of [14C] Antaitavir Hasophate	up to 15 days	To investigate the pharmacokinetics of total radioactivity in plasma after oral \[14C\] Antaitavir Hasophate in healthy subjects, and the distribution ratio of total radioactivity in whole blood and plasma
Cumulative excretion of [14C] Antaitavir Hasophate -related material (radioactivity in plasma, urine and fecal samples)	up to 15 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 Antaitavir Hasophate	up to 15 days	Proportion of different metabolites(Antaitavir Hasophate and main metabolites）
Quantitive analysis of the concentrations of Antaitavir Hasophate and main metabolites in plasma using the validated LC-MS/MS to obtain pharmacokinetic data	up to 15 days	The concentrations of Antaitavir Hasophate and main metabolites in plasma
Number of adverse events (AE) experienced by subjects	up to 15 days	To examine the safety and tolerability of \[14C\] Antaitavir Hasophate given orally

Trial Locations

Locations (1)

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