- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05873426
Mass Balance Study of [14C]ZSP1273 in Healthy Adult Male Subjects in China
July 16, 2023 updated by: Guangdong Raynovent Biotech Co., Ltd
Single-center, Open-label, Non-randomized and Single-dose Clinical Trial to Explore the Mass Balance of Oral Suspension of 600mg [14C]ZSP1273
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Suzhou, China
- The First Affiliated Hospital of Suzhou University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Males and female participates 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);
- 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:
- 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.
- Participates who donated blood or bleeding profusely(> 400 mL)in the 3 months preceding study screening.
- 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;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: [14C]ZSP1273
|
600 mg suspension containing 50μCi of [14C]ZSP1273
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total radioactivity in plasma PK: Cmax
Time Frame: Up to 14 days from the start of administration.
|
Up to 14 days from the start of administration.
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Total radioactivity in plasma PK: AUC0-t
Time Frame: Up to 14 days from the start of administration.
|
Up to 14 days from the start of administration.
|
Total radioactivity in plasma PK: CL/F
Time Frame: Up to 14 days from the start of administration.
|
Up to 14 days from the start of administration.
|
Total radioactivity in plasma PK: Vz/F
Time Frame: Up to 14 days from the start of administration.
|
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)
Time Frame: Up to 14 days from the start of administration.
|
Up to 14 days from the start of administration.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
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.
Time Frame: Up to 14 days from the start of administration.
|
Up to 14 days from the start of administration.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 25, 2023
Primary Completion (Actual)
April 28, 2023
Study Completion (Actual)
April 28, 2023
Study Registration Dates
First Submitted
May 4, 2023
First Submitted That Met QC Criteria
May 15, 2023
First Posted (Actual)
May 24, 2023
Study Record Updates
Last Update Posted (Actual)
July 18, 2023
Last Update Submitted That Met QC Criteria
July 16, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- ZSP1273-22-10
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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