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Completed

NCT Number: NCT05446233

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

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.

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Key information

Conditions

Healthy Male Subjects

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai xuhui central hospital

Shanghai, Shanghai Municipality, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[14C] Antaitavir Hasophate

Drug

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

Primary outcomes

  1. Distribution ratio of total radioactivity in whole blood and plasma of [14C] Antaitavir Hasophate

    Time frame: 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

  2. Cumulative excretion of [14C] Antaitavir Hasophate -related material (radioactivity in plasma, urine and fecal samples)

    Time frame: up to 15 days

    Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces.

Secondary outcomes

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

    Time frame: up to 15 days

    Proportion of different metabolites(Antaitavir Hasophate and main metabolites）

  2. Quantitive analysis of the concentrations of Antaitavir Hasophate and main metabolites in plasma using the validated LC-MS/MS to obtain pharmacokinetic data

    Time frame: up to 15 days

    The concentrations of Antaitavir Hasophate and main metabolites in plasma

  3. Number of adverse events (AE) experienced by subjects

    Time frame: up to 15 days

    To examine the safety and tolerability of [14C] Antaitavir Hasophate given orally

Sponsors and collaborators

Lead sponsor

Sunshine Lake Pharma Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 6, 2022
Registry last updated
Jan 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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