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Mass Balance and Biotransformation Study of [14C]DBPR108 in Human | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Mass Balance and Biotransformation Study of [14C]DBPR108 in Human

A Clinical Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]DBPR108 in Chinese Healthy Adult Male Subjects- Mass Balance and Biotransformation Study of [14C]DBPR108 in Human

NCT05072028•CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a single-center, open-label phase I clinical study to evaluate the mass balance and biotransformation pathways of \[14C\]DBPR108 in Chinese healthy adult male subjects, to reveal the overall pharmacokinetic characteristics of DBPR108 in human body, and to provide a reference for the rational administration.

Detailed Description

This study will evaluate the mass balance and pharmacokinetics of DBPR108 in approximately 6 healthy male subjects receiving a single oral 100 mg dose of DBPR108 containing approximately 150 µCi of \[14C\]- DBPR108. This study consists of a screening period (Day -7 to Day -2), a baseline period (Day -1), a treatment period, and a follow-up visit period.

Eligibility

Age

18 - 45 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. Healthy male adults;
•2. 18 to 45 years (inclusive);
•3. Subjects weight ≥50.0 kg and body mass index (BMI) between18-26 kg/m\^2 (inclusive) (BMI= weight (kg)/height\^2 (m\^2);
•4. Medical history, vital signs examination, physical examination, laboratory tests (blood routine, blood biochemistry, urine routine, thyroid function) and other test results of subjects judged to be normal or abnormal without clinical significance;
•5. Voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions.

Exclusion Criteria

•1. Clinically significant abnormal results for physical examination, vital signs, routine laboratory tests (blood routine, blood biochemistry, coagulation routine, urine routine, stool routine + occult blood, thyroid function, glycated hemoglobin), 12-lead electrocardiogram (ECG), chest CT scan, and abdominal B-ultrasound (liver, gallbladder, pancreas, spleen, and kidney);
•2. Any positive test result of hepatitis B surface antigen, hepatitis C virus antibody, anti-human immunodeficiency virus antibody or anti-Treponema pallidum specific antibody;
•3. Subjects with a history of severe hypoglycemia, such as drowsiness, disturbance of consciousness, or even coma due to hypoglycemia;
•4. History of acute and chronic pancreatitis, or a history of cholecystitis, gallstones, and pancreatic injury and other high-risk factors that may cause pancreatitis;
•5. Subjects are hard to swallow, or have diseases affecting drug absorption, distribution, metabolism, excretion;
•6. History of gastrointestinal ulcer or bleeding;
•7. History of any clinically significant diseases, such as circulatory, endocrine, neurological, gastrointestinal, urinary, hematological, immunological, psychiatric and metabolic diseases;
•8. History of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torsade de pointes ventricular tachycardia, ventricular tachycardia, prolonged QT syndrome, or symptoms of prolonged QT syndrome and family history;
•9. Have a major surgery or incomplete incision healing within 6 months prior to screening. Major surgery includes, but is not limited to, any surgery involving a significant risk of bleeding, prolonged general anesthesia, or open biopsy or obvious traumatic injury;
•10. History of needle sickness or blood sickness, difficulty in blood collection or intolerance to venipuncture blood collection;
+16 more criteria

Locations (1)

First Affiliated Hospital of Soochow University

Suzhou, China

Key Dates

Start Date

November 16, 2021

Primary Completion Date

November 28, 2021

Completion Date

November 28, 2021

Last Updated

January 3, 2022

Enrollment

ACTUAL participants

Conditions

Healthy Male Subjects

Interventions

[14C]DBPR108

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 3, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Mass Balance and Biotransformation Study of [14C]DBPR108 in Human

Inclusion Criteria

Exclusion Criteria

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