Gout; HyperuricemiaPhase 1NCT02890966
Multiple Dose Study of SHR4640 in Healthy Subjects
A Phase 1 study testing SHR4640 in people with Gout; Hyperuricemia, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The objective of the study is to assess the tolerance, pharmacokinetic and pharmacodynamic properties of multiple dose adminstration of SHR4640 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gout; Hyperuricemia
- What is being tested?
- SHR4640
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Mar 2017
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 55, male;
- Body weight≥50, BMI:19-25kg/m2;
- 3.4 mg/dL≤Screening serum urate level≤7 mg/dL;
- 4.Medically stable based on physical examination, laboratory results, vital sign measurements, 12-lead electrocardiogram, abdomen B-ultrasound and Chest X-ray examination at screening.
Who cannot join
- Serum creatinine>upper limits of normal(ULN);
- Alanine aminotransferase and/or Aspartate aminotransferase>2×ULN, total bilirubin>1.5×ULN, glutamyltransferase>3×ULN;
- History of hyperuricemia or gout;
- History or suspicion of kidney stones;
- Positive results for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, syphilis antibody test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of SHR4640 in Healthy Subjects
The objective of the study is to assess the tolerance, pharmacokinetic and pharmacodynamic properties of multiple dose adminstration of SHR4640 in healthy volunteers.
- Conditions
- Gout; Hyperuricemia
- Being tested
- SHR4640, placebo
- Keywords
- SHR4640 pharmacokinetics pharmacodynamics
- Medical subject headings
- Gout, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR4640Drug
Day1~Day7:oral administration
placeboDrug
Day1~Day7:oral administration
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 1mg SHR4640 or placebo Receives: Drug: SHR4640; Drug: placebo |
| Cohort 2 | Experimental | 2.5mg SHR4640 or placebo Receives: Drug: SHR4640; Drug: placebo |
| Cohort 3 | Experimental | 5mg SHR4640 or placebo Receives: Drug: SHR4640; Drug: placebo |
| Cohort 4 | Experimental | 10mg SHR4640 or placebo Receives: Drug: SHR4640; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: Clinical significant changes from baseline up to Day 10
Secondary outcomes (6)
Peak Plasma Concentration(Cmax)(of single dose and at stable status)
Measured: Up to Day 10
Area under the plasma concentration versus time curve(AUC)(of single dose and at stable status)
Measured: Up to Day 10
Half-time(T1/2)(of single dose and at stable status)
Measured: Up to Day 10
Time to the peak plasma concentration(Tmax)(of single dose and at stable status)
Measured: Up to Day 10
Changes in serum uric acid concentration from baseline
Measured: Up to Day 10
Changes in urinary uric acid excretion from baseline
Measured: Up to Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startJul 2016
- Primary completionFeb 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gout; 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 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
- NCT02890966
- Sponsor's protocol ID
- SHR4640-102
- Status last verified
- Mar 2017
- First submitted
- 1 Sep 2016
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of SHR4640 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02890966
- Acronym / sponsor ID
- SHR4640-102
- Conditions
- Gout; Hyperuricemia
- Keywords
- SHR4640 pharmacokinetics pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 7 Sep 2016 (estimated)
- 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 tolerance, pharmacokinetic and pharmacodynamic properties of multiple dose adminstration of SHR4640 in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: SHR4640, Drug: placebo1mg SHR4640 or placebo |
| Cohort 2 | Experimental | Drug: SHR4640, Drug: placebo2.5mg SHR4640 or placebo |
| Cohort 3 | Experimental | Drug: SHR4640, Drug: placebo5mg SHR4640 or placebo |
| Cohort 4 | Experimental | Drug: SHR4640, Drug: placebo10mg SHR4640 or placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 55, male;
- Body weight≥50, BMI:19-25kg/m2;
- 3.4 mg/dL≤Screening serum urate level≤7 mg/dL;
- 4.Medically stable based on physical examination, laboratory results, vital sign measurements, 12-lead electrocardiogram, abdomen B-ultrasound and Chest X-ray examination at screening.
Key exclusion criteria (5 listed)
- Serum creatinine>upper limits of normal(ULN);
- Alanine aminotransferase and/or Aspartate aminotransferase>2×ULN, total bilirubin>1.5×ULN, glutamyltransferase>3×ULN;
- History of hyperuricemia or gout;
- History or suspicion of kidney stones;
- Positive results for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, syphilis antibody test.
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 |
|---|---|---|
| SHR4640Day1~Day7:oral administration | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| placeboDay1~Day7:oral administration | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Adverse events
Time frame: Clinical significant changes from baseline up to Day 10
6 secondary outcomes
Peak Plasma Concentration(Cmax)(of single dose and at stable status)
Time frame: Up to Day 10
Area under the plasma concentration versus time curve(AUC)(of single dose and at stable status)
Time frame: Up to Day 10
Half-time(T1/2)(of single dose and at stable status)
Time frame: Up to Day 10
Time to the peak plasma concentration(Tmax)(of single dose and at stable status)
Time frame: Up to Day 10
Changes in serum uric acid concentration from baseline
Time frame: Up to Day 10
Changes in urinary uric acid excretion from baseline
Time frame: Up to Day 10
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 30 Mar 2017.
- 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 SHR4640 in people with Gout; 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 4 inclusion and 5 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 30 Mar 2017. 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?
Adverse events (time frame: Clinical significant changes from baseline up to Day 10). 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 30 Mar 2017.