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

NCT05873426 | Completed Phase 1

• 1 other identifier: ZSP1273-22-10
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (5)

• Total radioactivity in plasma PK: Cmax

  Up to 14 days from the start of administration.

• Total radioactivity in plasma PK: AUC0-t

  Up to 14 days from the start of administration.

• Total radioactivity in plasma PK: CL/F

  Up to 14 days from the start of administration.

• Total radioactivity in plasma PK: Vz/F

  Up to 14 days from the start of administration.

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

  Up to 14 days from the start of administration.

Secondary Outcomes (2)

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

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

• 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.

  Up to 14 days from the start of administration.

Study Arms (1)

[14C]ZSP1273

EXPERIMENTAL

Drug: [14C] ZSP1273

Interventions

[14C] ZSP1273 DRUG

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

[14C]ZSP1273

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Raynovent Biotech Co., Ltd: lead

Study Sites (1)

The First affiliated hospital of Suzhou university

Suzhou, China

Location

MeSH Terms

Interventions

ZSP1273

Study Design

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

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 24, 2023
• Study Start: March 25, 2023
• Primary Completion: April 28, 2023
• Study Completion: April 28, 2023
• Last Updated: March 21, 2025

Record last verified: 2023-07

Locations

CN (1)