- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05040113
A Study On Human Mass Balance And Biotransformation
A Clinical Study to Evaluate Absorption, Metabolism and Excretion of [14C] CBP-307 in Healthy Chinese Male Adult Subjects - Human Mass Balance and Biotransformation Study of [14C] CBP-307
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Jiangsu
-
Suzhou, Jiangsu, China, 215006
- Connect Investigative Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- A healthy male adult
- Age: 18 to 45 years old (inclusive)
- Weight: body mass index (BMI) is between 19 and 26 kg/m2(inclusive), and weight of no less than 50 kg
- Subjects who are willing to sign Informed Consent Form
- Subjects should be able to communicate well with the investigator and be able to complete the study in accordance with the protocol
Exclusion Criteria:
-
Examinations:
- Any abnormal and clinically significant findings to physical examination, vital sign, routine laboratory tests (such as hematology, blood chemistry, blood coagulation function, urinalysis, fecal occult blood), thyroid function test, 12-lead ECG, chest CT, abdominal B-ultrasonography (liver, gallbladder, pancreas, spleen and kidney) and so on
- Heart rate at screening period < 60 bpm, or 12-lead ECG QTcF ≥450 msec
- Anyone has positive examination result of HBsAg/HBeAg, HCV antibody, HIV antibody and treponema pallidum antibody
Screening for novel coronavirus infection: clinically significant abnormity of C-reactive protein, or positive novel coronavirus nucleic acid
Medication history:
- Use of any drug that inhibits or induces the function of hepatic drug-metabolizing enzymes within 30 days prior to screening (see Appendix 1)
- Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines or food supplement such as vitamins, calcium supplement within 14 days prior to Screening
Use of any investigational drug within 3 months, or the drug withdrawal is less than 6 half-lives (whichever is longer) prior to successful enrollment for dosing
Medical history and surgery history:
- Any history of clinically serious disease, or presence of illness/condition that the investigator considers would affect the study results, including but not limited to the diseases of circulatory system, respiratory system, endocrine system, nervous system, digestive system, urinary system or history of blood, immune, mental and metabolic diseases
- History of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torsade ventricular tachycardia, ventricular tachycardia, AV block, QT prolongation syndrome, or QT prolongation symptoms and family history, indicated by genetic evidence or sudden death of a close relative due to cardiac conditions at a young age
- Major surgery history or surgical incision does not completely heal within 6 months prior to the screening; Major surgery includes, but is not limited to, any subject with significant bleeding risk, prolonged general anesthesia, incision of a biopsy or significant traumatic injury
- Allergic constitution, such as a known history of allergies to two or more substances; or may be allergic to the investigational product or its excipients based on the investigator's judgment
Suffering haemorrhoids or perianal disease with blood in the stool or regularly, irritable bowel syndrome, inflammatory bowel disease
Life style:
- Subjects have habitual constipation or diarrhoea
- Subjects are alcoholism, or frequent alcohol consumption within six months prior to screening, which means drinking more than 14 units of alcohol every week (one unit alcohol equals 360 mL of beer, 45 mL of 40% alcohol or 150 mL of wine); or the alcohol breath test result is ≥20 mg/dl in screening
- Subjects have smoked more than 5 cigarettes per day in three months before screening, or habitual use of nicotine products, and who can not quit smoking during the study
- Abusing drug, using soft drugs such as marijuana three months prior to screening, or using hard drugs such as cocaine, amphetamine, phencyclidine, etc. one year prior to screening; or urine test for drugs is positive at screening
Subjects have habitual drinking of grapefruit juice, excessive tea, coffee and/or caffeinated beverages, and who can not be abstained during the study
Others:
- Subjects who have to work in radioactive conditions in long time, participated in radio-labeled drug clinical study or had significant radioactive exposure within one year before the study, no less than 2 times of chest/abdominal CT, or no less than 3 times of different types of X-ray exam
- Subjects with a history of fear of needles, hemophobia, difficulty in blood collection or inability to tolerate venipuncture blood collection;
- Subjects who plan to have children or donate sperm during the study period and within 1 year after completion of the study, or those who disagree to take strict contraceptive measures during the study or within 1 year after completion of the study for themselves or their spouses (see Appendix 3 for details)
- Subjects who received any vaccine within 4 weeks before screening, or plan to receive the vaccine during the study
- Subjects, who have had blood loss/donation up to 400 mL within 3 months, or received blood transfusion within 1 month prior to screening
- Subjects determined by the investigators to be unsuitable for participating in this study for any reasons
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CBP-307
Take CBP-307orally at 30 min ± 2 min after the start of high-fat breakfast intake
|
CBP-307 capsules oral administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum concentration (Cmax)
Time Frame: Pre-dose and 1hour,2hour,4hour,6hour,7hour,8hour,10hour,12hour,24hour,48hour,72hour,96hour,120hour,144hour,168hour,216hour,264hour,312hour,360hour,408hour,456hour,504hour post-dose
|
Ratio of total radioactivity in whole blood to that in plasma
|
Pre-dose and 1hour,2hour,4hour,6hour,7hour,8hour,10hour,12hour,24hour,48hour,72hour,96hour,120hour,144hour,168hour,216hour,264hour,312hour,360hour,408hour,456hour,504hour post-dose
|
Cumulative recovery of total radioactivity in urine or/and feces
Time Frame: -24 to 0 hour predose to Day22
|
Percentage of each metabolite in urine and feces to the administered dose (% of administered dose) or percentage of circulating metabolites in plasma to total exposure AUC (% AUC)
|
-24 to 0 hour predose to Day22
|
Time to Peak (Tmax)
Time Frame: Pre-dose and 1hour,2hour,4hour,6hour,7hour,8hour,10hour,12hour,24hour,48hour,72hour,96hour,120hour,144hour,168hour,216hour,264hour,312hour,360hour,408hour,456hour,504hour post-dose
|
Ratio of total radioactivity in whole blood to that in plasma
|
Pre-dose and 1hour,2hour,4hour,6hour,7hour,8hour,10hour,12hour,24hour,48hour,72hour,96hour,120hour,144hour,168hour,216hour,264hour,312hour,360hour,408hour,456hour,504hour post-dose
|
Area under the curve (AUC0-t and AUC0-inf)
Time Frame: Pre-dose and 1hour,2hour,4hour,6hour,7hour,8hour,10hour,12hour,24hour,48hour,72hour,96hour,120hour,144hour,168hour,216hour,264hour,312hour,360hour,408hour,456hour,504hour post-dose
|
Ratio of total radioactivity in whole blood to that in plasma
|
Pre-dose and 1hour,2hour,4hour,6hour,7hour,8hour,10hour,12hour,24hour,48hour,72hour,96hour,120hour,144hour,168hour,216hour,264hour,312hour,360hour,408hour,456hour,504hour post-dose
|
Elimination half-life (t1/2)
Time Frame: Pre-dose and 1hour,2hour,4hour,6hour,7hour,8hour,10hour,12hour,24hour,48hour,72hour,96hour,120hour,144hour,168hour,216hour,264hour,312hour,360hour,408hour,456hour,504hour post-dose
|
Ratio of total radioactivity in whole blood to that in plasma
|
Pre-dose and 1hour,2hour,4hour,6hour,7hour,8hour,10hour,12hour,24hour,48hour,72hour,96hour,120hour,144hour,168hour,216hour,264hour,312hour,360hour,408hour,456hour,504hour post-dose
|
Apparent Clearance (CL/F)
Time Frame: Pre-dose and 1hour,2hour,4hour,6hour,7hour,8hour,10hour,12hour,24hour,48hour,72hour,96hour,120hour,144hour,168hour,216hour,264hour,312hour,360hour,408hour,456hour,504hour post-dose
|
Ratio of total radioactivity in whole blood to that in plasma
|
Pre-dose and 1hour,2hour,4hour,6hour,7hour,8hour,10hour,12hour,24hour,48hour,72hour,96hour,120hour,144hour,168hour,216hour,264hour,312hour,360hour,408hour,456hour,504hour post-dose
|
Apparent Volume of Distribution (Vd/F)
Time Frame: Pre-dose and 1hour,2hour,4hour,6hour,7hour,8hour,10hour,12hour,24hour,48hour,72hour,96hour,120hour,144hour,168hour,216hour,264hour,312hour,360hour,408hour,456hour,504hour post-dose
|
Ratio of total radioactivity in whole blood to that in plasma
|
Pre-dose and 1hour,2hour,4hour,6hour,7hour,8hour,10hour,12hour,24hour,48hour,72hour,96hour,120hour,144hour,168hour,216hour,264hour,312hour,360hour,408hour,456hour,504hour post-dose
|
Mean Residence Time (MRT)
Time Frame: Pre-dose and 1hour,2hour,4hour,6hour,7hour,8hour,10hour,12hour,24hour,48hour,72hour,96hour,120hour,144hour,168hour,216hour,264hour,312hour,360hour,408hour,456hour,504hour post-dose
|
Ratio of total radioactivity in whole blood to that in plasma
|
Pre-dose and 1hour,2hour,4hour,6hour,7hour,8hour,10hour,12hour,24hour,48hour,72hour,96hour,120hour,144hour,168hour,216hour,264hour,312hour,360hour,408hour,456hour,504hour post-dose
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CBP-307CN004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Healthy Adult Subjects
-
BiogenCompletedHealthy Adult Subjects | Healthy Elderly SubjectsUnited States
-
PfizerCompletedHealthy Adult Subjects and Healthy Elderly SubjectsBelgium
-
IlDong Pharmaceutical Co LtdYUNOVIA CO.,LTD.RecruitingHealthy Adult SubjectsKorea, Republic of
-
The Affiliated Hospital of Qingdao UniversityChenland Nutritionals Inc.RecruitingHealthy Adult SubjectsChina
-
Trinomab Biotech Co., Ltd.TIGERMED AUSTRALIA PTY LIMITEDCompletedHealthy Adult SubjectsAustralia
-
Jiangsu HengRui Medicine Co., Ltd.CompletedHealthy Adult SubjectsChina
-
Mitsubishi Tanabe Pharma CorporationCompleted
-
Bausch Health Americas, Inc.CompletedHealthy Adult SubjectsUnited States
-
Bausch Health Americas, Inc.CompletedHealthy Adult SubjectsUnited States
-
Mitsubishi Tanabe Pharma CorporationCompleted
Clinical Trials on CBP-307
-
Suzhou Connect Biopharmaceuticals, Ltd.CompletedModerate to Severe Ulcerative ColitisUnited States, China, Pakistan, Ukraine
-
Suzhou Connect Biopharmaceuticals, Ltd.Tigermed Consulting Co., Ltd; Nucleus Network LtdCompleted
-
Connect Biopharma Australia Pty LtdCompletedAutoimmune DiseasesAustralia, United States
-
Contineum TherapeuticsRecruitingRelapsing Remitting Multiple SclerosisUnited States
-
Suzhou Connect Biopharmaceuticals, Ltd.Active, not recruiting
-
Hangzhou Jiayin Biotech LtdRecruitingSpinal Muscular Atrophy Type IChina
-
Pipeline Therapeutics, Inc.Completed
-
Coherent Biopharma (Hefei) Co., Ltd.RecruitingCancer, Breast | Cancer of Pancreas | Cancer Colorectal | Cancer, Lung | Cancer of EsophagusChina, United States
-
BioMarin PharmaceuticalActive, not recruiting
-
Pipeline Therapeutics, Inc.Completed