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Mass Balance and Biotransformation of [14C]HSK7653 in Human

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04540016
Recruitment Status : Recruiting
First Posted : September 7, 2020
Last Update Posted : September 7, 2020
The First Affiliated Hospital of Suzhou University
Information provided by (Responsible Party):
Sichuan Haisco Pharmaceutical Group Co., Ltd.

Brief Summary:
A single-center, single-dose, non-randomized, open-label design.

Condition or disease Intervention/treatment Phase
Type II Diabetes Drug: [14C]HSK7653 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: A single-center, single-dose, non-randomized, open-label design.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Trial on Absorption, Metabolism, and Excretion of [14C]HSK7653 in Healthy Adult Male Chinese Subjects - Mass Balance and Biotransformation of [14C]HSK7653 in Human
Estimated Study Start Date : October 15, 2020
Estimated Primary Completion Date : December 29, 2020
Estimated Study Completion Date : March 30, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Arm Ⅰ
25 mg of 80 µCi [14C]HSK7653.
Drug: [14C]HSK7653
25 mg of [14C]HSK7653 (radioactivity of 80 µCi) capsules are taken under fasted condition.

Primary Outcome Measures :
  1. Percentage of cumulative drug excretion of [14C]HSK7653 on biological specimens(urine and faeces) accounting for total radiation drug dose [ Time Frame: From the start of administration to 50 day after administration ]
    Though collecting different periods of biological specimens(urine and faeces) , detecting their respective drug excretion of [14C]HSK7653,calculating the total cumulative excretion amount and relevant proportion of each kind of specimen(urine or faeces).

  2. Peak concentration (Cmax) [ Time Frame: From the start of administration to 50 day after administration ]
    Pharmacokinetic Measures

  3. Area under the concentration-time curve (AUC0-t, AUC0-∞) [ Time Frame: From the start of administration to 50 day after administration ]
    Pharmacokinetic Measures

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Healthy Chinese males, aged 18-45 years old (inclusive);
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Healthy Chinese males, aged 18-45 years old (inclusive);
  2. Body weight ≥ 50.0 kg and body mass index (BMI) between 19.0-26.0 kg/m2 (inclusive);
  3. Subjects who voluntarily sign the informed consent form (ICF), able to communicate with the investigator and to complete all trial procedures as per the protocol.-

Exclusion Criteria:

Those who meet any of the following should not be enrolled:

Clinical examination:

  1. Clinically significant abnormal results for comprehensive physical examination, vital signs, routine laboratory tests [blood routine, blood biochemistry, coagulation routine, urine routine, stool routine + occult blood, thyroid function, oral glucose tolerance test (fasting blood glucose, 2-hour blood glucose), glycated hemoglobin], visual acuity and ophthalmic examination (slit lamp, introcular pressure, and fundoscopy), 12-lead electrocardiogram (ECG), chest X-ray (anteriorposterior), and abdominal B-ultrasound (liver, gallbladder, pancreas, spleen, and kidney);
  2. Positive for hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV antibody, or Treponema pallidum antibodies;

    Medication history:

  3. Use of any Western medicine or Chinese patent medicine (including prescription drug, over-the-counter drug, health care product, or live attenuated influenza vaccine) within 14 days prior to screening;
  4. Participation in any clinical trial and interference with other investigational drug or medical device within 3 month prior to screening;

    Medical history and surgical history:

  5. History of serious clinical diseases or diseases/conditions that the investigator believes may affect the study results, including but not limited to the history of diseases in the motor system, nervous system, endocrine system, circulatory system, respiratory system, digestive system, urinary system, and reproductive system;
  6. Past history of organic heart disease, heart failure, myocardial infarction, angina, unexplained arrhythmia, torsades de pointes, ventricular tachycardia, long QT syndrome or symptoms and familial history of long QT syndrome (indicated by genetic evidence or sudden death of a close relative at a young age due to cardiac causes);
  7. Have undergone major surgery within 6 months prior to screening or with incomplete healing of the surgical incision; major surgery includes, but is not limited to, any surgery with significant risk of bleeding, prolonged general anesthesia, or incisional biopsy or obvious traumatic injury (excluding cured appendicitis surgery or rectal prolapse surgery);
  8. Severe allergic constitution, including known allergy to DPP-4 inhibitors or any excipient of this investigational product (mannitol, microcrystalline cellulose), two or more drugs and food components, or with special dietary requirements and thus unable to follow a standardized diet;
  9. With commitment acute/chronic bronchospasm (asthma, chronic obstructive pulmonary disease), pulmonary fibrosis, pulmonary tuberculosis, untreated pneumonitis, or other diseases that affect respiratory function;
  10. History of severe hypoglycemic seizure (such as hypoglycemia-induced somnolence, disturbance of consciousness, disorganized speech, or even coma), or history of severe hypoglycemia unawareness;
  11. Volunteers judged by the investigator to be unsuitable for participating in this trial for any reason.-

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04540016

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Contact: Shiping Ma, PhD 028-82378557
Contact: Kai Chen, PhD 028-82378557

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the First Affilicated Hospital of Soochow University Recruiting
Suzhou, China
Contact: miao liyan, PhD    0371-66295219      
Sponsors and Collaborators
Sichuan Haisco Pharmaceutical Group Co., Ltd.
The First Affiliated Hospital of Suzhou University
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Principal Investigator: Liyan Miao, PhD Medical Ethics Committee of the First Affiliated Hospital of soochow University
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Responsible Party: Sichuan Haisco Pharmaceutical Group Co., Ltd. Identifier: NCT04540016    
Other Study ID Numbers: HSK7653-103
First Posted: September 7, 2020    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases