Clinical trial
A Single-center, Open-label, Single-arm, Fixed-sequence Study to Evaluate the Pharmacokinetic Effects of SHR0302 Tablets on Substrates of CYP3A4, CYP2C8, CYP2C9, CYP2C19 in Healthy Volunteers
Name
SHR0302-111
Description
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 repaglinide as probe drugs.
Trial arms
Trial start
2022-07-15
Estimated PCD
2022-08-18
Trial end
2022-08-18
Status
Completed
Phase
Early phase I
Treatment
SHR0302 Tablets
SHR0302 Tablets once daily
Arms:
single arm
Midazolam Maleate Tablets
Midazolam Maleate Tablets single dose
Arms:
single arm
Warfarin Sodium Tablets
Warfarin Sodium Tablets single dose
Arms:
single arm
Omeprazole Enteric Capsules
Omeprazole Enteric Capsules single dose
Arms:
single arm
Vitamin K1 Tablets
Vitamin K1 Tablets once daily
Arms:
single arm
Repaglinide Tablets
Repaglinide Tablets single dose
Arms:
single arm
Size
24
Primary endpoint
Cmax,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Days 1-29
AUC0-t,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Days 1-29
AUC0-inf,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Days 1-29
Eligibility criteria
Inclusion Criteria:
- 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 Criteria:
1. Subjects with known history or suspected of being allergic to the study drugs;
2. Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening
3. Subjects with eGFR less than 90 mL/min/1.73m2;
4. 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;
5. Subjects whoes12-Lead ECG QTcF was more than 450 ms or there were other abnormalities determined by the investigator;
6. Subjects with clinically significant abnormalities in coagulation function;
7. Subjects with infectious disease;
8. Subjects with positive of urine drug screen;
9. Subjects with acute illness occurred within 4 weeks prior to the screening period;
10. Subjects who required antimicrobial therapy within 4 weeks prior to the screening period;
11. Subjects with medical history of systemic inflammatory disease, autoimmune disease, recurrent herpes zoster, disseminated herpes zoster, disseminated herpes simplex;
12. Subjects with a history of tuberculosis (TB) within six months prior to the screening period;
13. Subjects with a history of hypoglycemic episodes or fasting blood glucose less than 2.8 mmol/L during screening;
14. Subjects who took inhibitors or inducers of CYP3A4, CYP2C8, CYP2C9, or CYP2C19 within 28 days before the study;
15. Subjects with contraindications for midazolam, warfarin, omeprazole, and repaglinide.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single-center, single arm, open-label, fixed sequence, self-control', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}
Updated at
2022-12-22
1 organization
6 products
1 indication
Organization
Jiangsu HengRui MedicineProduct
Midazolam MaleateIndication
Rheumatoid ArthritisProduct
OmeprazoleProduct
RepaglinideProduct
SHR0302Product
WarfarinProduct
Vitamin K1