GoutPhase 1NCT03131583
The Drug-Drug Interaction of SHR4640, Febuxostat and Colchicine in Patients With Gout
A Phase 1 study testing Colchicine, Febuxostat and SHR4640 in people with Gout, 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, Febuxostat and Colchicine interaction in patients with gout. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gout
- What is being tested?
- Colchicine, Febuxostat and SHR4640
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 17 Feb 2017to 29 Jan 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has a body mass index ≥18.5 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；
- sCr>ULN;
- History of kidney stones or screening kidney stones by B-ultrasound；
- History of malignancy within 5 years；
- 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
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
About this study
Official title: A Phase I, Single-Center, Open-Label, Single-Group Study to Evaluate Potential Pharmacodynamics of Drug-Drug Interaction Between SHR4640 and Febuxostat and Between SHR4640 and Colchicine in Patients With Gout
The objective of the study is to assess the pharmacodynamic properties of drug-drug of SHR4640, Febuxostat and Colchicine interaction in patients with gout.
- Conditions
- Gout
- Being tested
- Colchicine, Febuxostat, SHR4640
- Keywords
- SHR4640 Febuxostat Colchicine pharmacodynamics
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Day-14~Day16 qd
FebuxostatDrug
Day1 and Day8 qd
SHR4640Drug
Day3~Day8 qd
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Colchicine 0.5 mg Oral Tablet Day-14~Day16 qd, Febuxostat 80 mg Oral Tablet Day1 and Day8 qd, SHR4640 10 mg Oral Tablet Day3~Day8 qd. Receives: Drug: Colchicine; Drug: Febuxostat; Drug: SHR4640 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximun observed concentration (Cmax) of Febuxostat and Colchicine from plasma
PK profile
Measured: Clinical significant changes from baseline up to Day 8
Area under the concentration-time curve (AUC) of Febuxostat and Colchicine from plasma
PK profile
Measured: Clinical significant changes from baseline up to Day 8
Apparent terminal half-life (t1/2) of Febuxostat and Colchicine from plasma
PK profile
Measured: Clinical significant changes from baseline up to Day 8
Secondary outcomes (4)
Incidence of Adverse events
Safety issue
Measured: Clinical significant changes from Day-14 up to Day 16
Changes in Laboratory Values
Safety issue
Measured: Clinical significant changes from Day-14 up to Day 16
Changes in Electrocardiogram
Safety issue
Measured: Clinical significant changes from Day-14 up to Day 16
Changes in Vital Signs Parameters
Safety issue
Measured: Clinical significant changes from Day-14 up to Day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start17 Feb 2017
- Primary completion29 Jan 2018
- Study completion29 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT03131583
- Sponsor's protocol ID
- SHR4640-103
- Status last verified
- Aug 2019
- First submitted
- 27 Feb 2017
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Center, Open-Label, Single-Group Study to Evaluate Potential Pharmacodynamics of Drug-Drug Interaction Between SHR4640 and Febuxostat and Between SHR4640 and Colchicine in Patients With Gout
- ClinicalTrials.gov ID
- NCT03131583
- Acronym / sponsor ID
- SHR4640-103
- Conditions
- Gout
- Keywords
- SHR4640 Febuxostat Colchicine pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Feb 2017 (actual)
- Primary completion
- 29 Jan 2018 (actual)
- Study completion
- 29 Jan 2018 (actual)
- First posted
- 27 Apr 2017 (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, Febuxostat and Colchicine interaction in patients with gout.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Colchicine, Drug: Febuxostat, Drug: SHR4640Colchicine 0.5 mg Oral Tablet Day-14~Day16 qd, Febuxostat 80 mg Oral Tablet Day1 and Day8 qd, SHR4640 10 mg Oral Tablet Day3~Day8 qd. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject has a body mass index ≥18.5 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；
- sCr>ULN;
- History of kidney stones or screening kidney stones by B-ultrasound；
- History of malignancy within 5 years；
- 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 |
|---|---|---|
| ColchicineDay-14~Day16 qd | Drug | Cohort 1 |
| FebuxostatDay1 and Day8 qd | Drug | Cohort 1 |
| SHR4640Day3~Day8 qd | Drug | Cohort 1 |
Primary outcome
Maximun observed concentration (Cmax) of Febuxostat and Colchicine from plasma
Time frame: Clinical significant changes from baseline up to Day 8
PK profile
Area under the concentration-time curve (AUC) of Febuxostat and Colchicine from plasma
Time frame: Clinical significant changes from baseline up to Day 8
PK profile
Apparent terminal half-life (t1/2) of Febuxostat and Colchicine from plasma
Time frame: Clinical significant changes from baseline up to Day 8
PK profile
4 secondary outcomes
Incidence of Adverse events
Time frame: Clinical significant changes from Day-14 up to Day 16
Changes in Laboratory Values
Time frame: Clinical significant changes from Day-14 up to Day 16
Changes in Electrocardiogram
Time frame: Clinical significant changes from Day-14 up to Day 16
Changes in Vital Signs Parameters
Time frame: Clinical significant changes from Day-14 up to Day 16
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 8 Aug 2019.
- Individual participant dataSharing planned: No
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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 Colchicine, Febuxostat and SHR4640 in people with Gout, 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: finished, as of the sponsor's last update on 8 Aug 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?
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?
Maximun observed concentration (Cmax) of Febuxostat and Colchicine from plasma (time frame: Clinical significant changes from baseline up to Day 8). 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?
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 Aug 2019.