Evaluate the Effects of Food on the Pharmacokinetics of SIM0270

A Single Center, Randomized, Open Label, Single Dose, Two-Period, Crossover Phase I Study to Evaluate the Effect of Food (high-fat/standard Meal) on the Pharmacokinetics of SIM0270 in Healthy Adult Subjects in China

This is a randomized, open label, single dose, two-period, crossover trial phase I study.

The purpose of this study is to evaluate the food effect on the pharmacokinetics（PK） of SIM0270 after oral administration under fasted, standard meal, or high-fat diet conditions.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: SIM0270

Detailed Description

Part A High Fat Meal Test:

Sixteen healthy adult subjects are planned to be enrolled and randomly assigned to different dosing sequence groups (Group 1 and Group 2) in a 1:1 ratio for a two-period crossover trial. The subjects administered a single dose of SIM0270 under fasted, or high-fat diet conditions.

Part B Standard Meal Test (optional part):

Sixteen healthy adult subjects are planned to be enrolled and randomly assigned to different dosing sequence groups (Group 3 and Group 4) in a 1:1 ratio for a two-period crossover trial. The subjects administered a single dose of SIM0270 under fasted, or standard meal conditions.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250014
      • The First Affiliated Hospital of Shandong First Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Fully understand the study content, process, and potential risks of this trial, and voluntarily sign the informed consent.
2. Male and female subjects,age 18-65 years
3. Male subjects weigh ≥50 kg, female subjects weigh ≥45 kg; BMI ≥ 19 and ≤ 28kg/m^2.
4. Subjects of childbearing potential agree to take recognized effective contraceptive measures during the study period and within 6 months after the last dose of the investigational product, starting from signing the informed consent.

Exclusion Criteria:

1. Neurological/psychiatric, respiratory, cardiovascular, gastrointestinal, hematological and lymphatic, endocrine, skeletal-muscular disorders , hepatic or renal insufficiency, or any other disease or condition that may affect the results of the study or the safety of the subjects.
2. With dysphagia or any history of gastrointestinal diseases that affect drug absorption.
3. There are risk factors for apical torsion type ventricular tachycardia, or other clinically significant abnormalities determined by research doctors.
4. Have a history of active or latent tuberculosis.
5. History of malignant tumors. Excluding cervical carcinoma in situ, non melanoma skin cancer, or stage I uterine cancer (with a disease-free interval of at least 5 years) that have received appropriate treatment.
6. Investigator believe that any acute or chronic disease may limit the ability of participants to complete and/or participate in this clinical study.
7. Individuals who are allergic to the research drug or any component of the research drug, have a specific history of allergies, or have an allergic constitution
8. Have used hormone replacement therapy or selective estrogen modulators within the year prior to enrollment.
9. Have used oral antibiotics within 4 weeks before enrollment or intravenous antibiotics within 8 weeks.
10. Any medication/product known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, used or intended to be used within one month prior to enrollment.
11. Used any prescription drugs/products within 2 weeks prior to enrollment or any over-the-counter drugs within 1 week prior to enrollment.
12. Received CYP3A4 strong inhibitor or strong inducer medication within 2 weeks prior to administration after signing the informed consent form.
13. The results of laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function), physical examination, vital signs, 12 lead electrocardiogram examination, chest anteroposterior and lateral radiographs, and abdominal ultrasound examination were determined by the researchers to be abnormal and clinically significant.
14. Screening period (mean) or baseline electrocardiogram examination shows heart rate<60 or>100 and QTcF interval>450 ms.
15. Pregnant women with fertility test results are positive or pregnant or lactating women.
16. Those who are positive for hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus (HIV) antibody and treponema pallidum antibody.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-fat meal group（Group1）; Eight subjects were enrolled and administered single dose of 60mg SIM0270 under fasting condition in the first cycle, and administered single dose of 60mg SIM0270 under high-fat diet condition in the second cycle.	Drug: SIM0270; Use according to the prescribed protocol
Experimental: High-fat meal group（Group2）; Eight subjects were enrolled and administered single dose of 60mg SIM0270 under high-fat diet condition in the first cycle, and administered single dose of 60mg SIM0270 under fasting condition in the second cycle.	Drug: SIM0270; Use according to the prescribed protocol
Experimental: Standard meal group（Group3）; Eight subjects were enrolled and administered single dose of 60mg SIM0270 under fasting condition in the first cycle, and administered single dose of 60mg SIM0270 under standard meal condition in the second cycle.	Drug: SIM0270; Use according to the prescribed protocol
Experimental: Standard meal group（Group4）; Eight subjects were enrolled and administered single dose of 60mg SIM0270 under standard meal condition in the first cycle, and administered single dose of 60mg SIM0270 under fasting condition in the second cycle.	Drug: SIM0270; Use according to the prescribed protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameters: Peak Plasma Concentration (Cmax)	Comparison of PK parameters of SIM0270 single dose in Chinese healthy adult subjects under fasted/ high-fat diet conditions, or under fasted/ standard meal conditions.	Day1 to Day 37
PK parameters:Area under the plasma concentration versus time curve (AUC)	Comparison of PK parameters of SIM0270 single dose in Chinese healthy adult subjects under fasted/ high-fat diet conditions, or under fasted/ standard meal conditions.	Day1 to Day 37
PK parameters: Half-life (t1/2)	Comparison of PK parameters of SIM0270 single dose in Chinese healthy adult subjects under fasted/ high-fat diet conditions, or under fasted/ standard meal conditions.	Day1 to Day 37

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	The incidence and grading of adverse events, as well as abnormal indicators of vital signs, physical examination, electrocardiogram, and laboratory tests.	From signing ICF until 18 days after the last dose of medication

Collaborators and Investigators

• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Collaborators: Nanjing Zaiming Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2024
• Primary Completion (Actual): October 16, 2024
• Study Completion (Actual): October 16, 2024

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Estimated): December 2, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: SIM0270-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No