Mass Balance Clinical Trial of SIM0270

NCT06654791 | Active Not Recruiting Phase 1

• 1 other identifier: SIM0270-103
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, non-randomized, open-label, single-cohort, single-dose phase I clinical study in healthy Chinese adult male subjects.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (6)

• Mean Cumulative Amount of Total Radioactivity (CumAe) of [14C]SIM0270 Excreted in Urine, Feces, and Total (Urine and Feces Combined) Over the Entire Collection Period

  Following a single oral dose of 60 milligrams/150μCi of \[14C\]SIM0270, urine and fecal samples were collected over time from each participant. The amounts of total radioactivity excreted in the samples were determined using liquid scintillation counting.

  From Day 1 to Day 44

• Mean Cumulative Amount of Total Radioactivity Expressed as a Percentage of the Radioactive Dose Administered (CumFe) of [14C]SIM0270 Recovered in Urine, Feces, and Total (Urine and Feces Combined) Over the Entire Collection Period

  Following a single oral dose of 60 milligrams/150μCi of \[14C\]SIM0270, urine and fecal samples were collected over time from each participant. The amounts of total radioactivity excreted in the samples were determined using liquid scintillation counting.

  From Day 1 to Day 44

• Maximum 0bserved Concentration (Cmax), Estimated for SIM0270 in Plasma and for Total Radioactivity in Plasma

  Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of SIM0270 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.

  From 0 to 432 hours

• Time to Maximum 0served Concentration (Tmax), Estimated for SIM0270 in Plasma and for Total Radioactivity in Plasma

  Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of SIM0270 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.

  From 0 to 432 hours

• Area Under the Concentration-Time Curve From Time 0 to 432 Hours AUC(0-432), Estimated for SIM0270 in Plasma and for Total Radioactivity in Plasma

  Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of SIM0270 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.

  From 0 to 432 hours

• Terminal Elimination Half-Life (t1/2), Estimated for SIM0270 in Plasma and for Total Radioactivity in Plasma

  Pharmacokinetic parameters were estimated where possible and appropriate for each participant profile by non-compartmental analysis methods using Phoenix WinNonlin software. Plasma concentrations of SIM0270 were determined using liquid chromatography with tandem mass spectrometry. Total radioactivity concentrations in plasma and whole blood were determined using liquid scintillation counting.

  From 0 to 432 hours

Secondary Outcomes (1)

• The incidence of Adverse events

  From signing ICF until 14 days after departure from the study.

Study Arms (1)

[14C]SIM0270 group

OTHER

Single arm study

Drug: [14C] SIM0270 Oral Preparation

Interventions

[14C] SIM0270 Oral Preparation DRUG

Use according to the prescribed protocol

[14C]SIM0270 group

Eligibility Criteria

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

You may qualify if:

• The subjects fully understand the test content, process and possible adverse reactions, voluntarily sign informed consent, have good communication with the researchers, and can complete all the test procedures in accordance with the protocol.
• Chinese male, aged between 18 and 45 years old (including the critical value, subject to the signing of the informed consent).
• Weight ≥50.0kg, and body mass index (BMI) between 19.0 and 26.0 kg/m2 (including the cut-off value).

You may not qualify if:

• Clinical examination:
• Patients who have undergone physical examination, vital signs, laboratory examination (blood routine, blood biochemistry, thyroid function, coagulation function, urine routine, stool analysis), vision and eye examination (slit-lamp, intraocular pressure and fundus photography), X-ray chest film (anterior and lateral), abdominal B-ultrasound (liver, bile, pancreas, spleen and kidney) and other abnormal examinations with clinical significance;
• Patients with abnormal 12-lead ECG and clinical significance (including but not limited to: complete left bundle branch block; Right bundle branch block; First, second, or third degree heart block), or QTcF \> 450 ms after correction using the Fridericia formula (QTcF=QT / {(60/ heart rate)\^0.33});
• Hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody positive;
• Medication history:
• Those who have used prescription drugs, non-prescription drugs, health drugs or live attenuated vaccines including western medicines or proprietary Chinese medicines within 14 days before the screening period;
• Those who participated in any clinical trial and received the experimental drug or medical device intervention within 3 months prior to the screening period;
• Any drug with a strong/medium acting inhibitor or a strong/medium acting inducer of CYP3A4 in the 4 weeks prior to enrollment (see Appendix 1).
• Disease history and surgical history:
• Have been or are currently suffering from any clinically serious disease of the cardiovascular system, digestive system, respiratory system, endocrine system, nervous system, hematology, immunology, skin, tumor, psychiatric and metabolic abnormalities, or any other disease or physiological condition that can interfere with the test results;
• The presence of risk factors for Torsade de Pointes (such as a history of heart failure, hypokalemia, or a family history of prolonged QT syndrome), or a history of sick sinus syndrome, or a history of previous myocardial infarction;
• Patients who have undergone major surgery or whose surgical incision has not fully healed within the 6 months prior to the screening period, including but not limited to any surgery with significant bleeding risk, extended period of general anesthesia or open biopsy or significant traumatic injury (except surgery for recovered appendicitis or proctocele);
• Severe allergy, including allergy to the investigational drug or any excipient in the investigational drug, allergy to two or more other drugs or food ingredients;
• Those who have special requirements for diet and cannot comply with a unified diet;
• Perianal disease with regular/bleeding stool;

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead
• Nanjing Zaiming Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, 250014, 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: October 21, 2024
• First Posted: October 23, 2024
• Study Start: October 17, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)