Clincosm LogoSign in Get a demo

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

Sponsor
Guangdong Raynovent Biotech Co., Ltd (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05873426
Collaborator
(none)
6
Enrollment
1
Location
1
Arm
2.2
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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 participates, revealing the overall pharmacokinetic characteristics of ZSP1273.

Condition or Disease Intervention/Treatment Phase
  • Drug: [14C] ZSP1273
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Single-center, Open-label, Non-randomized and Single-dose Clinical Trial to Explore the Mass Balance of Oral Suspension of 600mg [14C]ZSP1273
Actual Study Start Date :
Mar 25, 2023
Actual Primary Completion Date :
May 4, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: [14C]ZSP1273

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

Outcome Measures

Primary Outcome Measures

  1. Total radioactivity in plasma PK: Cmax [Up to 14 days from the start of administration.]

  2. Total radioactivity in plasma PK: AUC0-t [Up to 14 days from the start of administration.]

  3. Total radioactivity in plasma PK: CL/F [Up to 14 days from the start of administration.]

  4. Total radioactivity in plasma PK: Vz/F [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) [Up to 14 days from the start of administration.]

Secondary Outcome Measures

  1. Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 [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. [Up to 14 days from the start of administration.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. Males and female participates between 18-45 years (Both inclusive);

  2. 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);

  3. Participates who voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions.

Exclusion Criteria:

  1. 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).

  2. Presence of human immunodeficiency virus (HIV), viral hepatitis(including hepatitis C virus (HCV) or hepatitis B virus (HBV) ,treponema pallidum antibodies at screening.

  3. Participates who donated blood or bleeding profusely(> 400 mL)in the 3 months preceding study screening.

  4. Participates 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;

  5. 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;

  6. 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;

  7. 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;

  8. Participates who have special dietary requirements and cannot comply with a uniform diet;

  9. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First affiliated hospital of Suzhou university Suzhou China

Sponsors and Collaborators

  • Guangdong Raynovent Biotech Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Guangdong Raynovent Biotech Co., Ltd
ClinicalTrials.gov Identifier:
NCT05873426
Other Study ID Numbers:
  • ZSP1273-22-10
First Posted:
May 24, 2023
Last Update Posted:
May 24, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 24, 2023