Gout; HyperuricemiaPhase 1NCT02815839
Single 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 safety, tolerance, food effect, pharmacokinetic and pharmacodynamic properties of single dose adminstration of SHR4640 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Gout; Hyperuricemia
- What is being tested?
- SHR4640
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Feb 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body weight≥50, BMI:19-24kg/m2;
- Screening serum urate level ≤ 4.5 mg/dL for male and ≤ 3.5 mg/dL for female;
- Medically stable based on physical examination, medical history, laboratory results, vital sign measurements, and 12-lead electrocardiogram (ECG) at screening;
Who cannot join
- History of hyperuricemia or gout.
- Pregnancy or breastfeeding;
- History or suspicion of kidney stones;
- serum creatinine>1.5mg/dl for male, >1.2mg/dl for female;
- alanine aminotransferase and/or aspartate aminotransferase>2 upper limit of normal, or total bilirubin>2.5 upper limit of normal.
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 Safety, Tolerability, Food Effect, Pharmacokinetics, and Pharmacodynamics of Single Doses of SHR4640 in Healthy Subjects
The objective of the study is to assess the safety, tolerance, food effect, pharmacokinetic and pharmacodynamic properties of single dose adminstration of SHR4640 in healthy volunteers.
- Conditions
- Gout; Hyperuricemia
- Being tested
- SHR4640, Placebo
- Keywords
- urate transporter 1, SHR4640, single ascending dose, 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
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 2.5-mg SHR4640 or placebo Receives: Drug: SHR4640; Drug: Placebo |
| Cohort 2 | Experimental | 5-mg SHR4640 or placebo Receives: Drug: SHR4640; Drug: Placebo |
| Cohort 3 | Experimental | 7.5-mg SHR4640 or placebo Receives: Drug: SHR4640; Drug: Placebo |
| Cohort 4 | Experimental | 10-mg SHR4640 or placebo Receives: Drug: SHR4640; Drug: Placebo |
| Cohort 5 | Experimental | 20-mg 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 to Day 15; from baseline up to Day 19 for 7.5mg dose group
Secondary outcomes (10)
Peak Plasma Concentration (Cmax)
Measured: up to day 4; up to day 11 for 7.5mg dose group
Area under the plasma concentration versus time curve (AUC)
Measured: up to day 4; up to day 11 for 7.5mg dose group
Half-time (T1/2)
Measured: up to day 4; up to day 11 for 7.5mg dose group
Time to the peak plasma concentration (Tmax)
Measured: up to day 4; up to day 11 for 7.5mg dose group
Cmax of SHR4640 dosed after high-fat meal in 7.5mg dose group
Measured: up to day 11
AUC of SHR4640 dosed after high-fat meal in 7.5mg dose group
Measured: up to day 11
T1/2 of SHR4640 dosed after high-fat meal in 7.5mg dose group
Measured: up to day 11
Tmax of SHR4640 dosed after high-fat meal in 7.5mg dose group
Measured: up to day 11
Changes in serum uric acid concentration from baseline
absolute and percent changes in serum acid concentration
Measured: up to day 4; up to day 11 for 7.5mg dose group
Changes in urinary uric acid excretion from baseline
percent changes in urinary uric acid excretion from baseline
Measured: up to day 4; up to day 11 for 7.5mg dose group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startNov 2015
- Primary completionFeb 2017
- Study completionFeb 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
- 50 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
- NCT02815839
- Sponsor's protocol ID
- SHR4640-101
- Status last verified
- Jun 2016
- First submitted
- 27 Apr 2016
- Last updated
- 28 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 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 Safety, Tolerability, Food Effect, Pharmacokinetics, and Pharmacodynamics of Single Doses of SHR4640 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02815839
- Acronym / sponsor ID
- SHR4640-101
- Conditions
- Gout; Hyperuricemia
- Keywords
- urate transporter 1, SHR4640, single ascending dose, pharmacokinetics, pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 28 Jun 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 safety, tolerance, food effect, pharmacokinetic and pharmacodynamic properties of single 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
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: SHR4640, Drug: Placebo2.5-mg SHR4640 or placebo |
| Cohort 2 | Experimental | Drug: SHR4640, Drug: Placebo5-mg SHR4640 or placebo |
| Cohort 3 | Experimental | Drug: SHR4640, Drug: Placebo7.5-mg SHR4640 or placebo |
| Cohort 4 | Experimental | Drug: SHR4640, Drug: Placebo10-mg SHR4640 or placebo |
| Cohort 5 | Experimental | Drug: SHR4640, Drug: Placebo20-mg SHR4640 or placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body weight≥50, BMI:19-24kg/m2;
- Screening serum urate level ≤ 4.5 mg/dL for male and ≤ 3.5 mg/dL for female;
- Medically stable based on physical examination, medical history, laboratory results, vital sign measurements, and 12-lead electrocardiogram (ECG) at screening;
Key exclusion criteria (5 listed)
- History of hyperuricemia or gout.
- Pregnancy or breastfeeding;
- History or suspicion of kidney stones;
- serum creatinine>1.5mg/dl for male, >1.2mg/dl for female;
- alanine aminotransferase and/or aspartate aminotransferase>2 upper limit of normal, or total bilirubin>2.5 upper limit of normal.
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 | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
| Placebo | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
Primary outcome
Adverse events
Time frame: Clinical significant changes from baseline up to to Day 15; from baseline up to Day 19 for 7.5mg dose group
10 secondary outcomes
Peak Plasma Concentration (Cmax)
Time frame: up to day 4; up to day 11 for 7.5mg dose group
Area under the plasma concentration versus time curve (AUC)
Time frame: up to day 4; up to day 11 for 7.5mg dose group
Half-time (T1/2)
Time frame: up to day 4; up to day 11 for 7.5mg dose group
Time to the peak plasma concentration (Tmax)
Time frame: up to day 4; up to day 11 for 7.5mg dose group
Cmax of SHR4640 dosed after high-fat meal in 7.5mg dose group
Time frame: up to day 11
AUC of SHR4640 dosed after high-fat meal in 7.5mg dose group
Time frame: up to day 11
T1/2 of SHR4640 dosed after high-fat meal in 7.5mg dose group
Time frame: up to day 11
Tmax of SHR4640 dosed after high-fat meal in 7.5mg dose group
Time frame: up to day 11
Changes in serum uric acid concentration from baseline
Time frame: up to day 4; up to day 11 for 7.5mg dose group
Changes in urinary uric acid excretion from baseline
Time frame: up to day 4; up to day 11 for 7.5mg dose group
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 28 Feb 2017.
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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 3 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 28 Feb 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 to Day 15; from baseline up to Day 19 for 7.5mg dose group). 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 28 Feb 2017.