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

NCT05446233 | Completed Phase 1

• 1 other identifier: HEC74647-P-04/CRC-C2222
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Male Subjects

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Identification of the Proportion of different metabolites to determine biotransformation pathway of Antaitavir Hasophate

  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

  up to 15 days

• Number of adverse events (AE) experienced by subjects

  up to 15 days

Study Arms (1)

[14C] Antaitavir Hasophate

EXPERIMENTAL

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

Drug: [14C] Antaitavir Hasophate

Interventions

[14C] Antaitavir Hasophate DRUG

100 mg suspension containing 200µCi of \[14C\] Antaitavir Hasophate

[14C] Antaitavir Hasophate

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

Shanghai xuhui central hospital

Shanghai, Shanghai Municipality, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 6, 2022
• Study Start: November 15, 2022
• Primary Completion: January 2, 2023
• Study Completion: January 2, 2023
• Last Updated: January 5, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)