Status:
COMPLETED
A Pharmacokinetic Study to Evaluate the Drug Interaction Between SHR0302 and CYP Substrates in Healthy Volunteers
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Rheumatoid Arthritis
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
This is a drug-drug interaction study conducted in healthy volunteers to evaluate the pharmacokinetic effect of SHR0302 on CYP3A4, CYP2C9, CYP2C9, CYP2C19, using midazolam, s-warfarin, omeprazole, and...
Eligibility Criteria
Inclusion
- \- 1.18 ≤ age ≤45, healthy male; 2.Subjects with body weight ≥ 50 kg, and 19≤BMI ≤26 kg/m2 ； 3.Subjects must agree to take effective contraceptive methods from signing informed consent to 6 months after the last administration.
Exclusion
- Subjects with known history or suspected of being allergic to the study drugs；
- Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening
- Subjects with eGFR less than 90 mL/min/1.73m2；
- Subjects with systolic blood pressure less than 90 mmHg or more than 140 mmHg, and/or diastolic blood pressure less than 60 mmHg or more than 90 mmHg;
- Subjects whoes12-Lead ECG QTcF was more than 450 ms or there were other abnormalities determined by the investigator；
- Subjects with clinically significant abnormalities in coagulation function；
- Subjects with infectious disease；
- Subjects with positive of urine drug screen；
- Subjects with acute illness occurred within 4 weeks prior to the screening period;
- Subjects who required antimicrobial therapy within 4 weeks prior to the screening period;
- Subjects with medical history of systemic inflammatory disease, autoimmune disease, recurrent herpes zoster, disseminated herpes zoster, disseminated herpes simplex;
- Subjects with a history of tuberculosis (TB) within six months prior to the screening period;
- Subjects with a history of hypoglycemic episodes or fasting blood glucose less than 2.8 mmol/L during screening；
- Subjects who took inhibitors or inducers of CYP3A4, CYP2C8, CYP2C9, or CYP2C19 within 28 days before the study;
- Subjects with contraindications for midazolam, warfarin, omeprazole, and repaglinide.
Key Trial Info
Start Date :
July 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05392127
Start Date
July 15 2022
End Date
August 18 2022
Last Update
December 22 2022
Active Locations (1)
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1
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430000