Actively Recruiting
An Open-Label Drug Interaction Clinical Study to Evaluate Itraconazole, Rifampin, Midazolam and SIM0270 in Chinese Healthy Adult Participants
Led by Jiangsu Simcere Pharmaceutical Co., Ltd. · Updated on 2026-01-22
60
Participants Needed
1
Research Sites
42 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
An Open-Label Drug Interaction Clinical Study to Evaluate Itraconazole, Rifampin, Midazolam and SIM0270 in Chinese Healthy Adult Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must fully understand the study, voluntarily sign informed consent, communicate well with researchers, and complete all procedures.
- Cohorts 1 and 2: healthy males and females aged 18 to 55 years; Cohort 3: healthy males aged 18 to 55 years.
- Male participants must weigh at least 50 kg; female participants at least 45 kg; BMI between 19 and 26 kg/m2.
- Female participants of childbearing potential and males with partners of childbearing potential must agree to effective contraception during and for 6 months after the study.
You will not qualify if you...
- History or presence of neurological, psychiatric, respiratory, cardiovascular, gastrointestinal, urinary, blood, endocrine, musculoskeletal, liver or kidney disorders affecting safety or study results.
- History of swallowing or gastrointestinal absorption disorders.
- Risk factors for Torsade de Pointes or significant heart abnormalities.
- History of active or latent tuberculosis.
- History of malignancy except certain treated cancers disease-free for at least 5 years.
- Major surgery within 6 months before screening or planned during the study.
- Allergy to study drugs or components, or multiple drug/food allergies.
- Use of hormone therapy or selective estrogen mediators within 1 year before screening.
- Use of drugs affecting absorption, metabolism, or elimination within 4 weeks before screening.
- Use of prescription drugs within 2 weeks or over-the-counter medications within 1 week before screening.
- Abnormal lab tests, vital signs, ECG, chest X-ray, or abdominal ultrasound judged clinically significant.
- ECG heart rate below 60 or above 100 beats/min, or QTcF interval over 450 ms.
- Pregnant, lactating, or positive pregnancy test in women of childbearing potential.
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis.
- History of drug abuse or positive drug screening.
- Regular alcohol consumption above study limits or positive alcohol breath test.
- Smoking more than 5 cigarettes daily within 3 months before screening or inability to quit.
- Participation in other drug trials with interventions within 3 months before screening.
- Consumption of grapefruit or grapefruit-related products within 1 week before screening.
- Inability to comply with diet requirements.
- Difficulty with blood collection or history of fainting during blood draws.
- Blood donation or loss of more than 200 mL within 3 months before screening, or blood transfusion within 2 months.
- Any other conditions or reasons that would prevent study completion or participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shandong University of Qilu Hospital
Jinan, Shandong, China, 250100
Actively Recruiting
Research Team
Q
Qiuping Huang, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
3
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