Evaluate the Effects of Food on the Pharmacokinetics of SIM0270

NCT06536036 | Completed Phase 1

• 1 other identifier: SIM0270-102
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Adverse events

  From signing ICF until 18 days after the last dose of medication

Study Arms (4)

High-fat meal group（Group1）

EXPERIMENTAL

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

High-fat meal group（Group2）

EXPERIMENTAL

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

Standard meal group（Group3）

EXPERIMENTAL

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

Standard meal group（Group4）

EXPERIMENTAL

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

Interventions

SIM0270 DRUG

Use according to the prescribed protocol

High-fat meal group（Group1）; High-fat meal group（Group2）; Standard meal group（Group3）; Standard meal group（Group4）

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fully understand the study content, process, and potential risks of this trial, and voluntarily sign the informed consent.
• Male and female subjects,age 18-65 years
• Male subjects weigh ≥50 kg, female subjects weigh ≥45 kg; BMI ≥ 19 and ≤ 28kg/m\^2.
• 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.

You may not qualify if:

• 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.
• With dysphagia or any history of gastrointestinal diseases that affect drug absorption.
• There are risk factors for apical torsion type ventricular tachycardia, or other clinically significant abnormalities determined by research doctors.
• Have a history of active or latent tuberculosis.
• 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.
• Investigator believe that any acute or chronic disease may limit the ability of participants to complete and/or participate in this clinical study.
• 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
• Have used hormone replacement therapy or selective estrogen modulators within the year prior to enrollment.
• Have used oral antibiotics within 4 weeks before enrollment or intravenous antibiotics within 8 weeks.
• 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.
• Used any prescription drugs/products within 2 weeks prior to enrollment or any over-the-counter drugs within 1 week prior to enrollment.
• Received CYP3A4 strong inhibitor or strong inducer medication within 2 weeks prior to administration after signing the informed consent form.
• 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.
• Screening period (mean) or baseline electrocardiogram examination shows heart rate\<60 or\>100 and QTcF interval\>450 ms.
• Pregnant women with fertility test results are positive or pregnant or lactating women.

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: August 2, 2024
• Study Start: July 23, 2024
• Primary Completion: October 16, 2024
• Study Completion: October 16, 2024
• Last Updated: December 2, 2024

Record last verified: 2024-11

Locations

CN (1)