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
Overview
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Cumulative recovery of total radioactivity in urine or/and feces
Overview
Brief Summary
This study will evaluate the absorption,metabolism and excretion of CBP-307 in healthy chinese male subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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:
Arms & Interventions
CBP-307
Take CBP-307orally at 30 min ± 2 min after the start of high-fat breakfast intake
Intervention: CBP-307 (Drug)
Outcomes
Primary Outcomes
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)
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
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
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
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
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
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
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
Secondary Outcomes
No secondary outcomes reported