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

NCT04540016 | Completed Phase 1 DMC

• 1 other identifier: HSK7653-103
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type II Diabetes

Outcome Measures

Primary Outcomes (3)

• Percentage of cumulative drug excretion of [14C]HSK7653 on biological specimens(urine and faeces) accounting for total radiation drug dose

  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).

  From the start of administration to 50 day after administration

• Peak concentration (Cmax)

  Pharmacokinetic Measures

  From the start of administration to 50 day after administration

• Area under the concentration-time curve (AUC0-t, AUC0-∞)

  Pharmacokinetic Measures

  From the start of administration to 50 day after administration

Study Arms (1)

Arm Ⅰ

OTHER

25 mg of 80 µCi \[14C\]HSK7653.

Drug: [14C]HSK7653

Interventions

[14C]HSK7653 DRUG

25 mg of \[14C\]HSK7653 (radioactivity of 80 µCi) capsules are taken under fasted condition.

Arm Ⅰ

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Healthy Chinese males, aged 18-45 years old (inclusive)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Chinese males, aged 18-45 years old (inclusive);
• Body weight ≥ 50.0 kg and body mass index (BMI) between 19.0-26.0 kg/m2 (inclusive);
• 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.-

You may not qualify if:

• Those who meet any of the following should not be enrolled:
• Clinical examination:
• 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);
• Positive for hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV antibody, or Treponema pallidum antibodies;
• Medication history:
• 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;
• 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:
• 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;
• 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);
• 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);
• 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;
• With commitment acute/chronic bronchospasm (asthma, chronic obstructive pulmonary disease), pulmonary fibrosis, pulmonary tuberculosis, untreated pneumonitis, or other diseases that affect respiratory function;
• History of severe hypoglycemic seizure (such as hypoglycemia-induced somnolence, disturbance of consciousness, disorganized speech, or even coma), or history of severe hypoglycemia unawareness;
• Volunteers judged by the investigator to be unsuitable for participating in this trial for any reason.-

Sponsors & Collaborators

• Sichuan Haisco Pharmaceutical Group Co., Ltd: lead
• First Affiliated Hospital of Suzhou Medical College: collaborator

Study Sites (1)

the First Affilicated Hospital of Soochow University

Suzhou, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Liyan Miao, PhD

  Medical Ethics Committee of the First Affiliated Hospital of soochow University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: A single-center, single-dose, non-randomized, open-label design.

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: September 7, 2020
• Study Start: November 15, 2020
• Primary Completion: January 14, 2021
• Study Completion: January 21, 2021
• Last Updated: December 12, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)