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Completed

NCT Number: NCT05873426

Mass Balance Study of [14C]ZSP1273 in Healthy Adult Male Subjects in China

This study is a single-center, open-label, and single-dose clinical study to evaluate the mass balance, biotransformation and pharmacokinetics of [14C]ZSP1273 in healthy Chinese male participants, revealing the overall pharmacokinetic characteristics of ZSP1273.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

The First affiliated hospital of Suzhou university

Suzhou, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Males and female participants between 18-45 years (Both inclusive);
  • Body weight≥50kg.Body mass index (BMI) 18~28 kg/m2 (Both inclusive); BMI is determined by the following equation: BMI = weight/height2 (kg/m2);
  • Participants who voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions.

Exclusion criteria

  • Any clinically significant abnormality upon physical examination or in the clinical laboratory tests. History or presence of a clinically significant gastrointestinal, renal, hepatic, neurologic, hematic, endocrine, neoplastic, pulmonary, immune, psychiatric or cardiovascular and cerebrovascular disorder(s) (but not limited to above disorders).
  • Presence of human immunodeficiency virus (HIV), viral hepatitis(including hepatitis C virus (HCV) or hepatitis B virus (HBV) ,treponema pallidum antibodies at screening.
  • Participants who donated blood or bleeding profusely(> 400 mL)in the 3 months preceding study screening.
  • Participants who have undergone surgery within 6 months before the screening period or whose surgical incision is not completely healed; Major surgery includes, but is not limited to, any surgery with a significant risk of bleeding, or an open biopsy or significant traumatic injury;
  • Workers engaged in conditions requiring long-term exposure to radioactivity; Or have significant radiation exposure (≥2 chest/abdomen CT, or ≥3 other types of X-ray examinations) within 1 year before this study or have participated in the radiopharmaceutical labeling test;
  • Participates who smoked an average of >5 cigarettes per day in the previous 3 months or habitually used nicotine-containing products and were unable to quit during the trial period;
  • Substance abuse or use of soft drugs (e.g., marijuana) in the 3 months prior to the screening period or use of hard drugs (e.g., cocaine, amphetamines, phenylcyclohexidine, etc.) in the 1 year prior to the screening period; Or screening for positive urine drug abuse (drug) tests;
  • Participates who have special dietary requirements and cannot comply with a uniform diet;
  • History of allergic conditions or allergic diseases, or a history of allergic reactions attributed to ZSP1273 or any of the ingredients of its formulation or similar drugs.

Treatment and study plan

[14C] ZSP1273

Drug

600 mg suspension containing 50μCi of [14C]ZSP1273

Primary outcomes

  1. Total radioactivity in plasma PK: Cmax

    Time frame: Up to 14 days from the start of administration.

  2. Total radioactivity in plasma PK: AUC0-t

    Time frame: Up to 14 days from the start of administration.

  3. Total radioactivity in plasma PK: CL/F

    Time frame: Up to 14 days from the start of administration.

  4. Total radioactivity in plasma PK: Vz/F

    Time frame: Up to 14 days from the start of administration.

  5. Mass balance recovery of total radioactivity in all (urine, faeces) amount excreted (Ae) expressed as a percentage of the administered dose (%Ae)

    Time frame: Up to 14 days from the start of administration.

Secondary outcomes

  1. Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0

    Time frame: Up to 23 days (approx) from the start of administration.

  2. Quantitive analysis of the concentrations of ZSP1273 and its major metabolites(if applicable) in plasma using the validated LC-MS/MS to obtain pharmacokinetic data.

    Time frame: Up to 14 days from the start of administration.

Sponsors and collaborators

Lead sponsor

Guangdong Raynovent Biotech Co., Ltd

Industry

Registry information

Official study title

Single-center, Open-label, Non-randomized and Single-dose Clinical Trial to Explore the Mass Balance of Oral Suspension of 600mg [14C]ZSP1273

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 24, 2023
Registry last updated
Mar 21, 2025

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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