Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
7 participants
INTERVENTIONAL
2023-03-18
2023-09-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Clinical Trial of Mass Balance of [14C] TQ05105 in Healthy Chinese Subjects
NCT07293390
A Study On Human Mass Balance And Biotransformation
NCT05040113
Mass Balance Study of [14C] D-1553 in Chinese Healthy Adult Male Subjects
NCT06233916
Mass Balance and Biotransformation Study of [14C]LXI-15028 in Humans
NCT05883306
Study to Evaluate the Mass Babance and Biotransformation of [14C]SHR6390 in Healthy Adult Male Volunteers
NCT04616742
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
[14C]JT001
[14C]JT001
Subjects will receive approximately 300 mg/100 µCi of \[14C\]JT001 orally.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
[14C]JT001
Subjects will receive approximately 300 mg/100 µCi of \[14C\]JT001 orally.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age: 18-45 years old
3. Body weight: Body mass index (BMI) is between 19.0 and 26.0 kg/m2 (including boundary values), and the body weight of the subject is not less than 50.0 kg;
4. Voluntarily sign informed consent;
5. Subjects were able to complete the trail according to protocol.
Exclusion Criteria
2. The electrocardiogram was abnormal and was considered clinically significant by the investigators, or has a history of organic heart disease
3. Has hepatitis B (HBV) or hepatitis C (HCV) or HIV antibody and syphilis antibody positive;
4. Any drug that inhibits or induces the drug transporters P-gp and BCRP has been used within 30 days prior to the screening period
5. Any conditions that may affect drug absorption.
6. Previous antineoplastic therapy meets washout requirements.
7. Hemorrhoids or perianal disease with regular/ongoing blood in the stool, irritable bowel syndrome, inflammatory bowel disease
8. Habitual constipation or diarrhea.
9. Significant radioactive exposure within 1 year.
18 Years
45 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sponsor GmbH
OTHER
Shanghai Vinnerna Biosciences Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
JT016-001-I
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.