A Study On Human Mass Balance And Biotransformation

NCT05040113 | Completed Phase 1 FDA Drug

• 1 other identifier: CBP-307CN004
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the absorption,metabolism and excretion of CBP-307 in healthy chinese male subjects.

Conditions

Healthy Adult Subjects

Outcome Measures

Primary Outcomes (8)

• Maximum concentration (Cmax)

  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

  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)

  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)

  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)

  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)

  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)

  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)

  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

Study Arms (1)

CBP-307

EXPERIMENTAL

Take CBP-307orally at 30 min ± 2 min after the start of high-fat breakfast intake

Drug: CBP-307

Interventions

CBP-307 DRUG

CBP-307 capsules oral administration

CBP-307

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Connect Biopharm LLC: lead

Study Sites (1)

Connect Investigative Site

Suzhou, Jiangsu, 215006, China

Location

Study Officials

• Suzhou Connect

  Connect Biopharm LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: September 10, 2021
• Study Start: September 4, 2021
• Primary Completion: October 30, 2021
• Study Completion: October 30, 2021
• Last Updated: April 5, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)