Mass Balance Study of [14C]HSK31858 in Healthy Adult Male Chinese Subjects.

NCT06569784 | Active Not Recruiting Phase 1

• 1 other identifier: HSK31858-103
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, nonrandomized, and open design study to investigate the pharmacokinetics, mass balance, metabolism and excretion of HSK31858 in healthy male subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (9)

• Total radioactivity ecovery rates in urine

  Total radioactivity ecovery rates in urine at each time interval.

  during periods of 0-4 hours, 4-8 hours, 8-12 hours, 12-24 hours, 24-48 hours, 48-72 hours, 72-96 hours, 96-120 hours, 120-144 hours, 144-168 hours, 168-192 hours, 192-216 hours, 216-240 hours, 240-264 hours, 264-288 hours, and 288-312 hours post-dose

• Total radioactivity ecovery rates in feces

  Total radioactivity ecovery rates in feces at each time interval.

  during periods of 0-24 hours, 24-48 hours, 48-72 hours, 72-96 hours, 96-120 hours, 120-144 hours, 144-168 hours, 168-192 hours, 192-216 hours, 216-240 hours, 240-264 hours, 264-288 hours, and 288-312 hours post-dose

• Cumulative total radioactivity recovery rates

  Cumulative total radioactivity recovery rates of \[14C\]HSK31858 in excretion (urine and faeces) accounting for total radiation drug dose.

  From the start of administration to 312 hours post-dose

• Cmax of total radioactivity

  The pharmacokinetic parameters of total radioactivity in plasma

  From the start of administration to 312 hours post-dose

• AUC(0-t) of total radioactivity

  The pharmacokinetic parameters of total radioactivity in plasm

  From the start of administration to 312 hours post-dose

• AUC(0-∞) of total radioactivity

  The pharmacokinetic parameters of total radioactivity in plasm

  From the start of administration to 312 hours post-dose

• %AUC

  Human plasma parent drug and its metabolites as a percentage of total plasma radioactivity exposure

  From the start of administration to 312 hours post-dose

• % administered dose

  Human urine and feces parent drug and its metabolites as a percentage of administered dose

  From the start of administration to 312 hours post-dose

• Identification of the main metabolites

  Identification of the main metabolites of HSK31858 in plasma, urine, and feces.

  From the start of administration to 312 hours post-dose

Secondary Outcomes (7)

• AUC(0-t)

  From the start of administration to 312 hours post-dose

• AUC(0-∞)

  From the start of administration to 312 hours post-dose

• Cmax

  From the start of administration to 312 hours post-dose

• Tmax

  From the start of administration to 312 hours post-dose

• t1/2

  From the start of administration to 312 hours post-dose

Study Arms (1)

40 mg/120 μCi[14C]HSK31858

EXPERIMENTAL

\[14C\]HSK31858

Drug: [14C]HSK31858

Interventions

[14C]HSK31858 DRUG

A single oral dose of 40 mg/120 μCi \[14C\]HSK31858 after fasting for at least 10 hours.

40 mg/120 μCi[14C]HSK31858

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Chinese male subjects, Age: 18\~45 years old (inclusive);
• Body weight ≥50.0 kg and BMI of 19 to 26 kg/m\^2(inclusive);
• Subjects who voluntarily signed the informed consent form, are able to communicate with the investigator and complete all study procedures as per the protocol.

You may not qualify if:

• Clinical examination:
• After physical examination, vital signs, laboratory tests (hematology, blood biochemistry, coagulation, urinalysis, stool analysis + occult blood, thyroid function), ophthalmological examination (slit lamp, intraocular pressure and fundus photography), 12-lead electrocardiogram \[Fridericia-corrected QT (QTcF)-interval, which in men should be between 350-450ms (inclusive)\], chest X-ray (PA and lateral), and abdominal ultrasound (liver, gallbladder, pancreas, spleen, kidney) are abnormal and clinically significant;
• Subjects tested positive for hepatitis B surface antigen or E antigen, hepatitis C antibody, combined human immunodeficiency virus antigen/antibody (HIV-Ag/Ab), or Treponema pallidum antibody;
• Medication history:
• Subjects who have used prescription, over-the-counter, or healthcare drugs, including Western or proprietary Chinese medicines, within 14 days or 5 half-lives of the drug, whichever is longer, prior to screening;
• Subjects who have articipated in any clinical trial and received test drug or medical device intervention within 3 months prior to screening;
• Anyone who has used any drug that inhibits or induces CYP3A activity or P-gp inhibitors within 30 days prior to screening;
• Disease history and surgical history:
• Prior or current history of any clinically serious disease of the cardiovascular, digestive, respiratory, endocrine, neurological, haematological, immunological, dermatological, oncological, psychiatric, and metabolic abnormalities or any other disease or physiological condition capable of interfering with the study results;
• History of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torsades de pointes, ventricular tachycardia, atrioventricular block, QT prolongation syndrome, or symptoms of QT prolongation syndrome, or a family history of the disease (as evidenced by genetic predisposition or a close relative's sudden death from cardiac causes at a young age);
• Subjects with a previous diagnosis of periodontitis or/and palmoplantar hyperkeratosis who are screened with the following problems:
• Subjects with current signs of gingivitis/periodontitis;
• Subjects with a history of hyperkeratosis of the palms or soles or erythema;
• Subjects who had major surgery or incompletely healed surgical incisions within 6 months prior to the screening, including, but not limited to, any surgery with significant risk of bleeding, prolonged general anaesthesia or incisional biopsy, or significant traumatic injury (with the exception of healed surgery of appendicitis or prolapse of the anus);
• Subjects with hyperactive immune response, including: clear sensitive to DPP1 inhibitors or any excipients of the drug in this trial, allergy to two or more other drugs or food ingredients or special dietary requirements and inability to comply with a uniform diet;

Sponsors & Collaborators

• Xizang Haisco Pharmaceutical Co., Ltd: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location

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: August 19, 2024
• First Posted: August 26, 2024
• Study Start: May 30, 2024
• Primary Completion: July 2, 2024
• Study Completion: October 30, 2024
• Last Updated: August 26, 2024

Record last verified: 2024-08

Locations

CN (1)