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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Male Subjects
• Intervention / Treatment: Drug: [14C] Antaitavir Hasophate

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai Xuhui Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C] Antaitavir Hasophate; Eligible healthy male subjects received a single oral 100 mg (radioactivity of 200µCi) dose of [14C] Antaitavir Hasophate	Drug: [14C] Antaitavir Hasophate; 100 mg suspension containing 200µCi of [14C] Antaitavir Hasophate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution ratio of total radioactivity in whole blood and plasma of [14C] Antaitavir Hasophate	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	up to 15 days
Cumulative excretion of [14C] Antaitavir Hasophate -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 15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of the Proportion of different metabolites to determine biotransformation pathway of Antaitavir Hasophate	Proportion of different metabolites(Antaitavir Hasophate and main metabolites）	up to 15 days
Quantitive analysis of the concentrations of Antaitavir Hasophate and main metabolites in plasma using the validated LC-MS/MS to obtain pharmacokinetic data	The concentrations of Antaitavir Hasophate and main metabolites in plasma	up to 15 days
Number of adverse events (AE) experienced by subjects	To examine the safety and tolerability of [14C] Antaitavir Hasophate given orally	up to 15 days

Collaborators and Investigators

• Sponsor: Sunshine Lake Pharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Actual): January 2, 2023
• Study Completion (Actual): January 2, 2023

Study Registration Dates

• First Submitted: July 1, 2022
• First Submitted That Met QC Criteria: July 1, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): January 5, 2023
• Last Update Submitted That Met QC Criteria: January 4, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: HEC74647-P-04/CRC-C2222

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No