HyperuricemiaPhase 1NCT04157959
The Drug-Drug Interaction of SHR4640 and Febuxostat in Patients With Hyperuricemia
A Phase 1 study testing SHR4640 dose1 and Febuxostat dose2 in people with Hyperuricemia, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The objective of the study is to assess the pharmacodynamic properties of drug-drug of SHR4640 and Febuxostat interaction in patients with Hyperuricemia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hyperuricemia
- What is being tested?
- SHR4640 dose1 and Febuxostat dose2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 14 Oct 2019to 30 Jun 2020
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject has a body mass index ≥18 and ≤30 kg/m2;
- Screening sUA value ≥8mg/dl;
- Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination，imaging examination or safety laboratory values.
Who cannot join
- Subject known or suspected of being sensitive to the study drugs or its ingredient；
- ALT、AST、TBIL>ULN;
- History of kidney stones or screening kidney stones by B-ultrasound；
- History of malignancy；
- History of xanthinuria；
- Donated blood（≥400ml）within 3 months prior to screening or received transfusion of blood。
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of QingDao University
Qingdao, Shandong
Cao Yu, 0532-82911767, Caoyu1767@126.com
About this study
Official title: A Phase I, Single-Center, Open-Label Study to Evaluate Pharmacodynamics of Drug-Drug Interaction Between SHR4640 and Febuxostat in Patients With Hyperuricemia
The objective of the study is to assess the pharmacodynamic properties of drug-drug of SHR4640 and Febuxostat interaction in patients with Hyperuricemia.
- Conditions
- Hyperuricemia
- Being tested
- SHR4640 dose1, Febuxostat dose2
- Medical subject headings
- Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR4640 dose1Drug
Tablet,dose1,QD
Febuxostat dose2Drug
Tablet,dose2,QD
| Study group | Role | What they receive |
|---|---|---|
| SHR4640 | Experimental | SHR4640 dose1 Oral Tablet Day1~Day14 qd,Febuxostat dose2 Oral Tablet Day8 and Day14 qd. Receives: Drug: SHR4640 dose1; Drug: Febuxostat dose2 |
| Febuxostat | Experimental | Febuxostat dose2 Oral Tablet Day1 and Day14 qd, SHR4640 dose1 Oral Tablet Day8~Day14 qd. Receives: Drug: SHR4640 dose1; Drug: Febuxostat dose2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax) of SHR4640 and Febuxostat from plasma
Measured: Day1 to Day 14
Area under the plasma concentration versus time curve (AUC) of SHR4640 and Febuxostat from plasma
Measured: Day1 to Day 14
Secondary outcomes (2)
Apparent terminal half-life (t1/2) of SHR4640 and Febuxostat from plasma
Measured: Day1 to Day 14
Number of Participants With Adverse Events (AEs) and Serious Adverse Events
Laboratory indicators, 12-lead electrocardiogram (ECG), physical examination,vital signs, adverse events (NCI-CTC AE 5.0), etc.
Measured: Clinical significant changes from Day-21 up to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start14 Oct 2019
- Primary completion1 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
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 HyperuricemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
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
- NCT04157959
- Sponsor's protocol ID
- SHR4640-104
- Status last verified
- Nov 2019
- First submitted
- 4 Nov 2019
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang C, Yu Q, Jiang X, Deng Y, Sun F, Li X, Tao Y, Lin P, Ma Y, Zhu Y, Li C, Cao Y. A Drug-Drug Interaction Study of a Novel Selective Urate Reabsorption Inhibitor, SHR4640, and Xanthine Oxidase Inhibitor, Febuxostat, in Patients With Primary Hyperuricemia. J Clin Pharmacol. 2023 Feb;63(2):239-249. doi: 10.1002/jcph.2159. Epub 2022 Oct 20.
PubMed 36131360
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Center, Open-Label Study to Evaluate Pharmacodynamics of Drug-Drug Interaction Between SHR4640 and Febuxostat in Patients With Hyperuricemia
- ClinicalTrials.gov ID
- NCT04157959
- Acronym / sponsor ID
- SHR4640-104
- Conditions
- Hyperuricemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 8 Nov 2019 (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.
The objective of the study is to assess the pharmacodynamic properties of drug-drug of SHR4640 and Febuxostat interaction in patients with Hyperuricemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR4640 | Experimental | Drug: SHR4640 dose1, Drug: Febuxostat dose2SHR4640 dose1 Oral Tablet Day1~Day14 qd,Febuxostat dose2 Oral Tablet Day8 and Day14 qd. |
| Febuxostat | Experimental | Drug: SHR4640 dose1, Drug: Febuxostat dose2Febuxostat dose2 Oral Tablet Day1 and Day14 qd, SHR4640 dose1 Oral Tablet Day8~Day14 qd. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subject has a body mass index ≥18 and ≤30 kg/m2;
- Screening sUA value ≥8mg/dl;
- Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination，imaging examination or safety laboratory values.
Key exclusion criteria (6 listed)
- Subject known or suspected of being sensitive to the study drugs or its ingredient；
- ALT、AST、TBIL>ULN;
- History of kidney stones or screening kidney stones by B-ultrasound；
- History of malignancy；
- History of xanthinuria；
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 |
|---|---|---|
| SHR4640 dose1Tablet,dose1,QD | Drug | Febuxostat, SHR4640 |
| Febuxostat dose2Tablet,dose2,QD | Drug | Febuxostat, SHR4640 |
Primary outcome
Peak Plasma Concentration (Cmax) of SHR4640 and Febuxostat from plasma
Time frame: Day1 to Day 14
Area under the plasma concentration versus time curve (AUC) of SHR4640 and Febuxostat from plasma
Time frame: Day1 to Day 14
2 secondary outcomes
Apparent terminal half-life (t1/2) of SHR4640 and Febuxostat from plasma
Time frame: Day1 to Day 14
Number of Participants With Adverse Events (AEs) and Serious Adverse Events
Time frame: Clinical significant changes from Day-21 up to Day 29
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Derived from this study: PubMed 36131360Wang C, Yu Q, Jiang X, Deng Y, Sun F, Li X, Tao Y, Lin P, Ma Y, Zhu Y, Li C, Cao Y. A Drug-Drug Interaction Study of a Novel Selective Urate Reabsorption Inhibitor, SHR4640, and Xanthine Oxidase Inhibitor, Febuxostat, in Patients With Primary Hyperuricemia. J Clin Pharmacol. 2023 Feb;63(2):239-249. doi: 10.1002/jcph.2159. Epub 2022 Oct 20.
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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.
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 SHR4640 dose1 and Febuxostat dose2 in people with Hyperuricemia, 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 8 Nov 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cao Yu (0532-82911767, Caoyu1767@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax) of SHR4640 and Febuxostat from plasma (time frame: Day1 to Day 14). The study lists 2 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 NCT04157959, 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 8 Nov 2019.