A Pharmacokinetic Study to Evaluate the Drug Interaction Between SHR0302 and CYP Substrates in Healthy Volunteers
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SHR0302 Tablets
Midazolam Maleate Tablets
Warfarin Sodium Tablets
Omeprazole Enteric Capsules
Vitamin K1 Tablets
Repaglinide Tablets
Sponsored by
About this trial
This is an interventional basic science trial for Rheumatoid Arthritis
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:
- 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.
Sites / Locations
- Zhongnan Hospital of Wuhan University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single arm
Arm Description
SHR0302 Tablets + probe drugs (Midazolam Maleate Tablets + Warfarin Sodium Tablets+ Omeprazole Enteric Capsules+ Repaglinide Tablets) + Vitamin K1 Tablets
Outcomes
Primary Outcome Measures
Cmax,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
AUC0-t,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
AUC0-inf,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Secondary Outcome Measures
Tmax,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
t1/2,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
CL/F,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Vz/F,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Number of subjects with adverse events and severity of adverse events
Full Information
NCT ID
NCT05392127
First Posted
May 23, 2022
Last Updated
December 21, 2022
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05392127
Brief Title
A Pharmacokinetic Study to Evaluate the Drug Interaction Between SHR0302 and CYP Substrates in Healthy Volunteers
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
July 15, 2022 (Actual)
Primary Completion Date
August 18, 2022 (Actual)
Study Completion Date
August 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 repaglinide as probe drugs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Single-center, single arm, open-label, fixed sequence, self-control
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single arm
Arm Type
Experimental
Arm Description
SHR0302 Tablets + probe drugs (Midazolam Maleate Tablets + Warfarin Sodium Tablets+ Omeprazole Enteric Capsules+ Repaglinide Tablets) + Vitamin K1 Tablets
Intervention Type
Drug
Intervention Name(s)
SHR0302 Tablets
Intervention Description
SHR0302 Tablets once daily
Intervention Type
Drug
Intervention Name(s)
Midazolam Maleate Tablets
Intervention Description
Midazolam Maleate Tablets single dose
Intervention Type
Drug
Intervention Name(s)
Warfarin Sodium Tablets
Intervention Description
Warfarin Sodium Tablets single dose
Intervention Type
Drug
Intervention Name(s)
Omeprazole Enteric Capsules
Intervention Description
Omeprazole Enteric Capsules single dose
Intervention Type
Drug
Intervention Name(s)
Vitamin K1 Tablets
Intervention Description
Vitamin K1 Tablets once daily
Intervention Type
Drug
Intervention Name(s)
Repaglinide Tablets
Intervention Description
Repaglinide Tablets single dose
Primary Outcome Measure Information:
Title
Cmax,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Time Frame
Days 1-29
Title
AUC0-t,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Time Frame
Days 1-29
Title
AUC0-inf,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Time Frame
Days 1-29
Secondary Outcome Measure Information:
Title
Tmax,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Time Frame
Days 1-29
Title
t1/2,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Time Frame
Days 1-29
Title
CL/F,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Time Frame
Days 1-29
Title
Vz/F,PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Time Frame
Days 1-29
Title
Number of subjects with adverse events and severity of adverse events
Time Frame
Up to 35 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
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.
Facility Information:
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Pharmacokinetic Study to Evaluate the Drug Interaction Between SHR0302 and CYP Substrates in Healthy Volunteers
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