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

Healthy Male Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05446233
• Other study ID #: HEC74647-P-04/CRC-C2222
• Status: Completed
• Phase: Phase 1
• Start date: November 15, 2022
• Est. completion date: January 2, 2023

Study information

• Verified date: November 2022
• Source: Sunshine Lake Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• 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] Antaitavir Hasophate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 2, 2023
• Est. primary completion date: January 2, 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

Related Conditions & MeSH terms

• Healthy Male Subjects

Intervention

Drug:
• [14C] Antaitavir Hasophate
100 mg suspension containing 200µCi of [14C] Antaitavir Hasophate

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	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
Primary	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	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
Secondary	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
Secondary	Number of adverse events (AE) experienced by subjects	To examine the safety and tolerability of [14C] Antaitavir Hasophate given orally	up to 15 days