Actively Recruiting
An Open-Label Drug Interaction Study Evaluating Itraconazole, Rifampin, Midazolam, and SIM0270 in Healthy Chinese Adults
Led by Jiangsu Simcere Pharmaceutical Co., Ltd. · Updated on 2026-01-22
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting an open-label, fixed-sequence Phase 1 clinical trial to study drug interactions in healthy adult Chinese participants. The study plans to enroll three cohorts of 16 to 20 participants each, including both males and females in the first two cohorts and males only in the third. The trial evaluates the effects of itraconazole, rifampin, midazolam, and SIM0270 on each other's pharmacokinetics in healthy adults aged 18 to 55 years. Participants receive oral doses of the study drugs in different cohorts: Cohort 1 assesses the impact of itraconazole on SIM0270, Cohort 2 evaluates rifampin's effect on SIM0270, and Cohort 3 studies how SIM0270 affects midazolam. The study is non-randomized and open-label, with no masking. The treatment periods include multiple days of dosing and follow-up for pharmacokinetic measurements. During the trial, participants undergo various assessments including blood sampling to measure drug concentrations and pharmacokinetic parameters such as maximum concentration, area under the curve, and half-life. Safety evaluations include physical exams, vital signs, ECGs, laboratory tests, and monitoring for adverse effects. The total study duration and detailed monitoring schedules are aligned with the pharmacokinetic sampling days.
CONDITIONS
Brief 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, provide informed consent, communicate well, and follow the protocol.
- 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; body mass index between 19 and 26 kg/m2.
- Participants of childbearing potential must agree to use effective contraception during the study and for 6 months after the last dose.
You will not qualify if you...
- History or presence of neurological, psychiatric, respiratory, cardiovascular, gastrointestinal, urinary, blood, endocrine, muscle, liver, or kidney diseases affecting safety or study results.
- History of swallowing difficulties or gastrointestinal disorders affecting drug absorption.
- Risk factors for heart rhythm problems or clinically 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.
- Allergies to study drugs or multiple allergies to drugs or foods.
- Use of hormone therapy within 1 year before screening.
- Use of drugs altering absorption or metabolism within 4 weeks before screening.
- Use of prescription drugs within 2 weeks or over-the-counter supplements within 1 week before screening.
- Abnormal lab tests or vital signs as judged clinically significant.
- Heart rate below 60 or above 100 bpm or prolonged QTc interval.
- Pregnancy, lactation, or positive pregnancy test.
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis.
- History or positive screening for drug abuse.
- Regular heavy alcohol use or smoking more than 5 cigarettes per day.
- Participation in other drug trials within 3 months before screening.
- Consumption of grapefruit or caffeine/alcohol within specified periods before screening.
- Special dietary requirements incompatible with study diet.
- Difficulty with blood draws or history of fainting during blood collection.
- Recent blood donation or transfusion.
- Other conditions judged unsuitable for participation or completion of the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 32 days
Participants receive oral study drugs including SIM0270, itraconazole, rifampin, and midazolam in a sequential manner to evaluate drug interactions.
Multiple visits during treatment period
Trial Site Locations
Total: 1 location
1
Shandong University of Qilu Hospital
Jinan, Shandong, China, 250100
Actively Recruiting
Research Team
Q
Qiuping Huang, Master
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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