Trials Sponsors Conditions Drugs Pricing

Conditions

Peripheral Analgesic and Anti-itch

Outcome Measures

Primary Outcomes (1)

Mass balance
Percentage of cumulative drug excretion of \[14C\]HSK21542 on biological pecimens(urine and faeces) accounting for total radiation drug dose.
From the start of administration to 240 h after administration

Secondary Outcomes (2)

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

Study Arms (1)

Arms

EXPERIMENTAL

2 μg/0.212 μCi/kg \[14C\]HSK21542

Drug: [14C]HSK21542

Interventions

[14C]HSK21542Drug

A single intravenous dose of 2 μg/0.212 μCi/kg \[14C\]HSK21542 in boluses within 2 minute after fasting for at least 10 hours.

Arms

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 45 Years

Sexmale(Gender-based eligibility)

Gender Eligibility DetailsHealthy Chinese males, aged 18-45 years old (inclusive)

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy Chinese males, aged 18-45 years old (inclusive);

Sponsors & Collaborators

The First Affiliated Hospital of Soochow University
Othercollaborator
Haisco Pharmaceutical Group Co., Ltd.
Industrylead

Study Sites (1)

f the First Affiliated Hospital of soochow University

Suzhou, Jiangsu, China

Related Publications (1)

Yuan JJ, Bian YC, Ma S, Chen W, Zhang FY, Zhang H, Miao LY. Pharmacokinetics, Mass Balance and Metabolism of [14C]HSK21542, a Novel Kappa Opioid Receptor Agonist, in Humans. Eur J Drug Metab Pharmacokinet. 2023 Nov;48(6):723-731. doi: 10.1007/s13318-023-00858-0. Epub 2023 Oct 13.
PMID: 37833493DERIVED

Study Officials

Liyan Miao, PhD
Medical Ethics Committee of the First Affiliated Hospital of soochow University
PRINCIPAL INVESTIGATOR

Enrollment

6 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

April 19, 2023

First Posted

April 28, 2023

Study Start

June 15, 2021

Actual (reported)

You may not qualify if:

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;
Living habits:
Long-term excessive consumption (more than 8 cups a day, 1 cup =250mL) of tea, grapefruit, coffee, drinks containing caffeine or grapefruit;
Subjects with a history of alcohol abuse in the three months prior to screening, with an average daily intake of more than 15 g of alcohol (15 g of alcohol is equivalent to 360 mL of beer or 150 mL of wine or 50 mL of liquor containing 40% alcohol), or with a positive alcohol breath test (test value greater than 20 mg/100 mL);
Subjects who smoked more than 5 cigarettes a day or habitually used nicotine-containing products in the 3 months before the screening period and could not quit during the test period;
Drug abuse or dependence, urine screening positive for drug abuse;
+4 more criteria

Pharmacokinetics, Mass Balance, and Metabolism of [14C]HSK21542 in Healthy Adult Male Volunteers.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Arms

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Arms

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations