An Open-Label Drug Interaction Clinical Study to Evaluate Itraconazole, Rifampin, Midazolam and SIM0270 in Chinese Healthy Adult Participants

NCT07357610 | Recruiting Phase 1

• 1 other identifier: SIM0270-104
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an open-label, fixed-sequence, two-period Phase 1 clinical trial in healthy adult Chinese participants with a total of 3 cohorts, 16-20 healthy adult Chinese participants are planned to be enrolled in each cohort.

Conditions

Healthy Adult Participants

Outcome Measures

Primary Outcomes (13)

• Maximum observed concentration (Cmax) of SIM0270

  To determine the effect of itraconazole on the PK of a single dose of SIM0270 in Chinese healthy adult participants.

  Day 1-Day 13, Day 16-Day 30

• Area under concentration curve from time 0 to the last quantifiable concentration (AUC0-t) of SIM0270

  To determine the effect of itraconazole on the PK of a single dose of SIM0270 in Chinese healthy adult participants.

  Day 1-Day 13, Day 16-Day 30

• Area under concentration-time curve from time 0 to infinity (AUC0-∞) of SIM0270

  To determine the effect of itraconazole on the PK of a single dose of SIM0270 in Chinese healthy adult participants.

  Day 1-Day 13, Day 16-Day 30

• Area under concentration-time curve from time 0 to tau (AUC0-tau) of SIM0270

  To determine the effect of itraconazole on the PK of a single dose of SIM0270 in Chinese healthy adult participants.

  Day 1-Day 13, Day 16-Day 30

• Terminal half-life（t1/2）of SIM0270

  To determine the effect of itraconazole on the PK of a single dose of SIM0270 in Chinese healthy adult participants.

  Day 1-Day 13, Day 16-Day 30

• Maximum observed concentration (Cmax) of SIM0270

  To determine the effect of rifampicin on the PK of a single dose of SIM0270 in Chinese healthy adult participants.

  Day 1-Day 13, Day 20-Day 32

• Area under concentration curve from time 0 to the last quantifiable concentration (AUC0-t) of SIM0270

  To determine the effect of rifampicin on the PK of a single dose of SIM0270 in Chinese healthy adult participants.

  Day 1-Day 13, Day 20-Day 32

• Area under concentration-time curve from time 0 to infinity (AUC0-∞) of SIM0270

  To determine the effect of rifampicin on the PK of a single dose of SIM0270 in Chinese healthy adult participants

  Day 1-Day 13, Day 20-Day 32

• Terminal half-life（t1/2）of SIM0270

  To determine the effect of rifampicin on the PK of a single dose of SIM0270 in Chinese healthy adult participants.

  Day 1-Day 13, Day 20-Day 32

• Maximum observed concentration (Cmax) of midazolam

  To determine the effect of SIM0270 on the PK of a single dose of midazolam in Chinese healthy adult male participants.

  Day 1-Day 2, Day 11-Day 13

• Area under concentration curve from time 0 to the last quantifiable concentration (AUC0-t) of Midazolam

  To determine the effect of SIM0270 on the PK of a single dose of midazolam in Chinese healthy adult male participants.

  Day 1-Day 2, Day 11-Day 13

• Area under concentration-time curve from time 0 to infinity (AUC0-∞) of Midazolam

  To determine the effect of SIM0270 on the PK of a single dose of midazolam in Chinese healthy adult male participants.

  Day 1-Day 2, Day 11-Day 13

• Terminal half-life（t1/2）of midazolam

  To determine the effect of SIM0270 on the PK of a single dose of midazolam in Chinese healthy adult male participants.

  Day 1-Day 2, Day 11-Day 13

Study Arms (3)

Cohort 1 : to evaluate the effect of the CYP3A4 inhibitor itraconazole on the pharmacokinetics of SI

EXPERIMENTAL

Cohort 1 is planned to enroll 16-20 healthy adult participants, both male and female

Drug: SIM0270; Drug: itraconazole

Cohort 2: to evaluate the effect of CYP3A4 inducer rifampin on the pharmacokinetics of SIM0270.

EXPERIMENTAL

Cohort 2 is planned to enroll 16-20 healthy adult participants, both male and female.

Drug: SIM0270; Drug: Rifampin

Cohort 3: to evaluate the effect of SIM0270 on the pharmacokinetics of the CYP3A4 substrate midazol

EXPERIMENTAL

Cohort 3 is planned to enroll 16-20 healthy adult participants，male only

Drug: SIM0270; Drug: midazolam

Interventions

SIM0270 DRUG

oral

Cohort 1 : to evaluate the effect of the CYP3A4 inhibitor itraconazole on the pharmacokinetics of SI; Cohort 2: to evaluate the effect of CYP3A4 inducer rifampin on the pharmacokinetics of SIM0270.; Cohort 3: to evaluate the effect of SIM0270 on the pharmacokinetics of the CYP3A4 substrate midazol

itraconazole DRUG

oral

Cohort 1 : to evaluate the effect of the CYP3A4 inhibitor itraconazole on the pharmacokinetics of SI

Rifampin DRUG

oral

Cohort 2: to evaluate the effect of CYP3A4 inducer rifampin on the pharmacokinetics of SIM0270.

midazolam DRUG

oral

Cohort 3: to evaluate the effect of SIM0270 on the pharmacokinetics of the CYP3A4 substrate midazol

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The participant 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.
• Cohorts 1 and 2: healthy male and female participants aged ≥ 18 and ≤ 55 years; Cohort 3: healthy male participants aged ≥ 18 and ≤ 55 years.
• Male participants weigh ≥ 50 kg; Female participants weigh ≥ 45 kg; Body mass index ≥ 19 kg/m2 and ≤ 26 kg/m2.
• Cohorts 1 and 2: all female participants of childbearing potential and male participants with partners of women 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; Cohort 3: male participants with partners of women 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:

• Past/Ongoing Medical History
• Neurological/psychiatric, respiratory, cardiovascular, gastrointestinal, urinary, hematological and lymphatic, endocrine, skeletal-muscular disorders, especially hepatic and renal insufficiency, or any other disease and condition that may affect the results of the study or the safety of the participants.
• History of dysphagia or any gastrointestinal disorder affecting drug absorption.
• Presence of risk factors for Torsade de Pointes (e.g., history of heart failure, hypokalemia, family history of QT prolongation syndrome), or other clinically significant abnormalities judged by the study doctor (including but not limited to: complete left bundle branch block; right bundle branch block; first-, second-, or third-degree heart block; sick sinus syndrome or previous history of myocardial infarction).
• History of active or latent tuberculosis.
• History of malignancy. Except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin cancer, or stage I uterine cancer (disease-free interval of at least 5 years).
• Any acute or chronic condition that, in the opinion of the investigator, would limit the ability of participants to complete and/or participate in this clinical study.
• Surgical history • Those who have undergone major surgery within 6 months prior to screening or are scheduled to undergo surgery during the study and are judged by the investigator to be inappropriate for enrollment.
• History of allergy
• Allergic to the study drug or any component of the study drug, with a history of specific allergies (asthma, urticaria, eczema, etc.) or allergic constitution (e.g., those allergic to two or more drugs, food such as milk and pollen).
• Medication history
• Use of hormone replacement therapy or selective estrogen mediators within 1 year prior to screening.
• Use or planned use of any drug/product within 4 weeks prior to screening that would alter the process of drug absorption, metabolism, or elimination.
• Use of any prescription drugs/products within 2 weeks prior to screening or over-the-counter medications (including vitamins, minerals, phytotherapies, herbal and botanical preparations) within 1 week prior to screening.
• Screening or Baseline Examinations

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shandong University of Qilu Hospital

Jinan, Shandong, 250100, China

RECRUITING

MeSH Terms

Interventions

Itraconazole; Rifampin; Midazolam

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring

Central Study Contacts

Qiuping Huang, Master

CONTACT

86+15060083948; huangqiuping@zaiming.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 22, 2026
• Study Start: January 5, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)