Rheumatoid ArthritisPhase 1NCT05392127
A Pharmacokinetic Study to Evaluate the Drug Interaction Between SHR0302 and CYP Substrates in Healthy Volunteers
A Phase 1 study testing SHR0302 Tablets, Midazolam Maleate Tablets and Warfarin Sodium Tablets in people with Rheumatoid Arthritis, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- SHR0302 Tablets, Midazolam Maleate Tablets and Warfarin Sodium Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2022to 18 Aug 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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；
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- SHR0302 Tablets, Midazolam Maleate Tablets, Warfarin Sodium Tablets, Omeprazole Enteric Capsules, Vitamin K1 Tablets
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR0302 TabletsDrug
SHR0302 Tablets once daily
Midazolam Maleate TabletsDrug
Midazolam Maleate Tablets single dose
Warfarin Sodium TabletsDrug
Warfarin Sodium Tablets single dose
Omeprazole Enteric CapsulesDrug
Omeprazole Enteric Capsules single dose
Vitamin K1 TabletsDrug
Vitamin K1 Tablets once daily
Repaglinide TabletsDrug
Repaglinide Tablets single dose
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | SHR0302 Tablets + probe drugs (Midazolam Maleate Tablets + Warfarin Sodium Tablets+ Omeprazole Enteric Capsules+ Repaglinide Tablets) + Vitamin K1 Tablets Receives: Drug: SHR0302 Tablets; Drug: Midazolam Maleate Tablets; Drug: Warfarin Sodium Tablets; Drug: Omeprazole Enteric Capsules; Drug: Vitamin K1 Tablets; Drug: Repaglinide Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax，PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Measured: Days 1-29
AUC0-t，PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Measured: Days 1-29
AUC0-inf，PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Measured: Days 1-29
Secondary outcomes (5)
Tmax，PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Measured: Days 1-29
t1/2，PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Measured: Days 1-29
CL/F，PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Measured: Days 1-29
Vz/F，PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Measured: Days 1-29
Number of subjects with adverse events and severity of adverse events
Measured: Up to 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start15 Jul 2022
- Primary completion18 Aug 2022
- Study completion18 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-center, single arm, open-label, fixed sequence, self-control
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392127
- Sponsor's protocol ID
- SHR0302-111
- Status last verified
- Dec 2022
- First submitted
- 23 May 2022
- Last updated
- 22 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fu M, Luo L, Feng S, Lin H, Lu Z, Gu F, Fan Y, Wu B, Huang J, Shen K. Effect of SHR0302 on the pharmacokinetics of CYP3A4, CYP2C8, CYP2C9 and CYP2C19 probe substrates in healthy volunteers: A cocktail analysis. Br J Clin Pharmacol. 2023 Dec;89(12):3659-3668. doi: 10.1111/bcp.15856. Epub 2023 Aug 22.
PubMed 37464978
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05392127
- Acronym / sponsor ID
- SHR0302-111
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 18 Aug 2022 (actual)
- Study completion
- 18 Aug 2022 (actual)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center, single arm, open-label, fixed sequence, self-control
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Drug: SHR0302 Tablets, Drug: Midazolam Maleate Tablets, Drug: Warfarin Sodium Tablets, Drug: Omeprazole Enteric Capsules, Drug: Vitamin K1 Tablets, Drug: Repaglinide TabletsSHR0302 Tablets + probe drugs (Midazolam Maleate Tablets + Warfarin Sodium Tablets+ Omeprazole Enteric Capsules+ Repaglinide Tablets) + Vitamin K1 Tablets |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (15 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR0302 TabletsSHR0302 Tablets once daily | Drug | single arm |
| Midazolam Maleate TabletsMidazolam Maleate Tablets single dose | Drug | single arm |
| Warfarin Sodium TabletsWarfarin Sodium Tablets single dose | Drug | single arm |
| Omeprazole Enteric CapsulesOmeprazole Enteric Capsules single dose | Drug | single arm |
| Vitamin K1 TabletsVitamin K1 Tablets once daily | Drug | single arm |
| Repaglinide TabletsRepaglinide Tablets single dose | Drug | single arm |
Primary outcome
Cmax，PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Time frame: Days 1-29
AUC0-t，PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Time frame: Days 1-29
AUC0-inf，PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Time frame: Days 1-29
5 secondary outcomes
Tmax，PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Time frame: Days 1-29
t1/2，PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Time frame: Days 1-29
CL/F，PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Time frame: Days 1-29
Vz/F，PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302
Time frame: Days 1-29
Number of subjects with adverse events and severity of adverse events
Time frame: Up to 35 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Derived from this study: PubMed 37464978Fu M, Luo L, Feng S, Lin H, Lu Z, Gu F, Fan Y, Wu B, Huang J, Shen K. Effect of SHR0302 on the pharmacokinetics of CYP3A4, CYP2C8, CYP2C9 and CYP2C19 probe substrates in healthy volunteers: A cocktail analysis. Br J Clin Pharmacol. 2023 Dec;89(12):3659-3668. doi: 10.1111/bcp.15856. Epub 2023 Aug 22.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR0302 Tablets, Midazolam Maleate Tablets and Warfarin Sodium Tablets in people with Rheumatoid Arthritis, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax，PK parameters of midazolam, s-warfarin, omeprazole, Repaglinide before and after oral administration of SHR0302 (time frame: Days 1-29). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05392127, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.