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A Study On Human Mass Balance And Biotransformation

Sponsor
Suzhou Connect Biopharmaceuticals, Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT05040113
Collaborator
(none)
6
Enrollment
1
Location
1
Arm
1.8
Actual Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
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
Actual Study Start Date :
Sep 4, 2021
Actual Primary Completion Date :
Oct 30, 2021
Actual Study Completion Date :
Oct 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: CBP-307

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

Drug: CBP-307
CBP-307 capsules oral administration

Outcome Measures

Primary Outcome Measures

  1. Maximum concentration (Cmax) [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

  2. Cumulative recovery of total radioactivity in urine or/and feces [-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)

  3. Time to Peak (Tmax) [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

  4. Area under the curve (AUC0-t and AUC0-inf) [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

  5. Elimination half-life (t1/2) [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

  6. Apparent Clearance (CL/F) [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

  7. Apparent Volume of Distribution (Vd/F) [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

  8. Mean Residence Time (MRT) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. A healthy male adult

  2. Age: 18 to 45 years old (inclusive)

  3. Weight: body mass index (BMI) is between 19 and 26 kg/m2(inclusive), and weight of no less than 50 kg

  4. Subjects who are willing to sign Informed Consent Form

  5. 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:

  1. 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

  2. Heart rate at screening period < 60 bpm, or 12-lead ECG QTcF ≥450 msec

  3. Anyone has positive examination result of HBsAg/HBeAg, HCV antibody, HIV antibody and treponema pallidum antibody

  4. Screening for novel coronavirus infection: clinically significant abnormity of C-reactive protein, or positive novel coronavirus nucleic acid

Medication history:

  1. Use of any drug that inhibits or induces the function of hepatic drug-metabolizing enzymes within 30 days prior to screening (see Appendix 1)

  2. 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

  3. 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:

  1. 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

  2. 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

  3. 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

  4. 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

  5. Suffering haemorrhoids or perianal disease with blood in the stool or regularly, irritable bowel syndrome, inflammatory bowel disease

Life style:

  1. Subjects have habitual constipation or diarrhoea

  2. 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

  3. 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

  4. 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

  5. Subjects have habitual drinking of grapefruit juice, excessive tea, coffee and/or caffeinated beverages, and who can not be abstained during the study

Others:

  1. 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

  2. Subjects with a history of fear of needles, hemophobia, difficulty in blood collection or inability to tolerate venipuncture blood collection;

  3. 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)

  4. Subjects who received any vaccine within 4 weeks before screening, or plan to receive the vaccine during the study

  5. Subjects, who have had blood loss/donation up to 400 mL within 3 months, or received blood transfusion within 1 month prior to screening

  6. Subjects determined by the investigators to be unsuitable for participating in this study for any reasons

Contacts and Locations

Locations

Site City State Country Postal Code
1 Connect Investigative Site Suzhou Jiangsu China 215006

Sponsors and Collaborators

  • Suzhou Connect Biopharmaceuticals, Ltd.

Investigators

  • Study Director: Suzhou Connect, Suzhou Connect Biopharmaceuticals, Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Suzhou Connect Biopharmaceuticals, Ltd.
ClinicalTrials.gov Identifier:
NCT05040113
Other Study ID Numbers:
  • CBP-307CN004
First Posted:
Sep 10, 2021
Last Update Posted:
Apr 5, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 5, 2022