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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05392127
Other study ID # SHR0302-111
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 15, 2022
Est. completion date August 18, 2022

Study information

Verified date December 2022
Source Jiangsu HengRui Medicine Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 repaglinide as probe drugs.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date August 18, 2022
Est. primary completion date August 18, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
SHR0302 Tablets
SHR0302 Tablets once daily
Midazolam Maleate Tablets
Midazolam Maleate Tablets single dose
Warfarin Sodium Tablets
Warfarin Sodium Tablets single dose
Omeprazole Enteric Capsules
Omeprazole Enteric Capsules single dose
Vitamin K1 Tablets
Vitamin K1 Tablets once daily
Repaglinide Tablets
Repaglinide Tablets single dose

Locations

Country Name City State
China Zhongnan Hospital of Wuhan University Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cmax,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302 Days 1-29
Primary AUC0-t,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302 Days 1-29
Primary AUC0-inf,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302 Days 1-29
Secondary Tmax,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302 Days 1-29
Secondary t1/2,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302 Days 1-29
Secondary CL/F,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302 Days 1-29
Secondary Vz/F,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302 Days 1-29
Secondary Number of subjects with adverse events and severity of adverse events Up to 35 days
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