A Phase I Clinical Study on Absorption, Metabolism, and Excretion of [14C]HSK21542 in Healthy Adult Male Chinese Subjects - Mass Balance and Biotransformation of [14C]HSK21542 in Human.

Haisco Pharmaceutical Group Co., Ltd.1 site in 1 country6 target enrollmentJune 15, 2021

ConditionsPeripheral Analgesic and Anti-itch

Interventions[14C]HSK21542

Drugs[14C]HSK21542

Overview

Phase: Phase 1
Intervention: [14C]HSK21542
Conditions: Peripheral Analgesic and Anti-itch
Sponsor: Haisco Pharmaceutical Group Co., Ltd.
Enrollment: 6
Locations: 1
Primary Endpoint: Mass balance
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single-center, nonrandomized, and open design study to investigate the pharmacokinetics, mass balance, metabolism and excretion of HSK21542 in healthy male subjects.

Registry

clinicaltrials.gov

Start Date

June 15, 2021

End Date

December 20, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Haisco Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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);
•Vital signs: blood pressure between 90-139/60-89 mmHg; heart rate or pulse between 60-99 beats/min;
•Subjects judged by the investigator based on past medical history, comprehensive physical examination, vital signs examination, and other prescribed tests;
•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

•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, 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 any excipient of this investigational product (Glacial acetic acid, sodium acetate, water for injection), two or more drugs and food components, or with special dietary requirements and thus unable to follow a standardized diet;

Arms & Interventions

Arms

2 μg/0.212 μCi/kg \[14C\]HSK21542

Intervention: [14C]HSK21542

Outcomes

Primary Outcomes

Mass balance

Time Frame: From the start of administration to 240 h after administration

Percentage of cumulative drug excretion of \[14C\]HSK21542 on biological pecimens(urine and faeces) accounting for total radiation drug dose.

Secondary Outcomes

Area under the concentration-time curve (AUC0-t, AUC0-∞)(From the start of administration to 240 h after administration)
Peak concentration (Cmax)(From the start of administration to 240 h after administration)