GoutPhase 1NCT03211403
Multiple Doses Study of SHR4640 in Male Subjects With High Serum Uric Acid Level
A Phase 1 study testing SHR4640 in people with Gout and Hyperuricemia, run by Atridia Pty Ltd. at 1 site in Australia.
Trial summary
This is a single-Center, randomized, double-Blind, placebo-controlled, multiple ascending-dose Phase I trail. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Gout, Hyperuricemia
- What is being tested?
- SHR4640
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- 4 Jul 2017to 15 Feb 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male, aged between 18 and 65 years, inclusive.
- Body weight ≥ 50 kg and body mass index between 18.0 and 35.0 kg/m2, inclusive.
- Screening sUA level ≥0.36 mmol/L.
- Considered generally healthy upon completion of medical history, full physical examination, vital signs, laboratory parameters (including thyroid function and serological tests, hematology, urinalysis, and biochemistry), 12-lead ECG, and abdominal ultrasound, as judged by the Investigator.
- Agrees to use a highly effective method of contraception, i.e. condom and suitable contraception for his female partner e.g. oral contraceptive or intrauterine contraceptive device during heterosexual intercourse or be non-heterosexually active, or practice sexual abstinence throughout the study period and for 30 days following final dose of study drug, and must agree to refrain from sperm donation from Day -2 until at least 30 days following final dose of study drug.
- Negative drug screen (including alcohol) at screening and on admission to clinical site.
- Able to understand the study procedures and the risks involved and must be willing to provide a written informed consent before any study-related activity.
Who cannot join
- History of hypersensitivity to SHR4640 or its analogues.
- History of gout.
- Screening alanine aminotransferase, aspartate aminotransferase, total bilirubin, or gamma glutamyl transferase > 1.5 × upper limit of normal.
- Positive result for human immunodeficiency virus (HIV).
- Positive result for hepatitis B surface antigen or hepatitis C virus antibody.
- History or presence of kidney stones.
Show all 20Show fewer
- Acute or chronic illness that, in the opinion of the Investigator, might confound the results of the trial or pose risk to the subject when administering the trial product.
- Undergone major surgery within 3 months of Day 1 or has surgery planned during study participation.
- Donated any blood or plasma in the past month or more than 400 mL within 3 months of Day 1.
- Has unsuitable venous for blood sampling.
- Use of tobacco products within 30 days of Day 1.
- Heavy caffeine drinker (more than 5 cups or glasses of caffeinated beverages per day).
- History of drug and/or alcohol abuse in the last year.
- Consumes more than 14 units of alcohol per week (1 unit = 250 mL beer, 25 mL of 40% spirits and 125 mL glass of wine).
- Consumes grapefruit and/or poppy seed within 5 days of Day 1.
- Unable to refrain from strenuous exercises, tobacco products, alcohol, grapefruit, and/or poppy seed from Day -2 to Day 10.
- Use of any of the following, unless agreed as nonclinically relevant by the Investigator and the Sponsor:
- 1) Prescription medication within 2 weeks of Day 1. 2) Over-the-counter medication within 1 week of Day 1. 3) Use of any over the-counter, nutraceuticals, or prescription medications that might interfere with the absorption, distribution, metabolism, or excretion of SHR4640 (proton-pump inhibitor, fluconazole, indomethacin, ranitidine, flurbiprofen, probenecid, aprepitant, etc.) within 1 month of Day 1.
- 18. Received the last dose of a study drug (or treatment with a medical device) within 30 days or 5 T1/2 (whichever is longer) of the study drug of Day 1 or are currently participating in another study of a study drug (or medical device).
- 19. Any other medical or psychological condition, which in the opinion of the Investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements or to complete the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of SHR4640 in Male Subjects With High Serum Uric Acid Level
This is a single-Center, randomized, double-Blind, placebo-controlled, multiple ascending-dose Phase I trail.
- Conditions
- Gout, Hyperuricemia
- Being tested
- SHR4640
- 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
SHR4640 or placebo once daily for a week
| Study group | Role | What they receive |
|---|---|---|
| SHR4640 2.5mg | Experimental | 6 subjects assigned to 2.5mg SHR4640 and 2 subjects assigned to placebo Receives: Drug: SHR4640 |
| SHR4640 10mg | Experimental | 6 subjects assigned to 10mg SHR4640 and 2 subjects assigned to placebo Receives: Drug: SHR4640 |
| SHR4640 20mg | Experimental | 6 subjects assigned to 20mg SHR4640 and 2 subjects assigned to placebo Receives: Drug: SHR4640 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse events in terms of changes in Hematology
Hemoglobin Hematocrit Erythrocytes count Mean cell volume, Mean cell hemoglobin concentration, Leukocytes count, Neutrophils count, Lymphocytes count, Monocytes count, Eosinophils count, Basophils count, Platelets count
Measured: Up to Day 14
Incidence of Adverse events in terms of changes in Urinalysis
Urobilinogen Dipstick urinalysis, including: pH, Specific gravity, Protein, Blood, Leukocytes, Glucose, Ketones, Bilirubin, Nitrites
Measured: Up to Day 14
Incidence of Adverse events in terms of changes in Biochemistry (fasting)
Including Serum creatinine, Urea, Alanine aminotransferase, Aspartate aminotransferase, Gamma glutamyl transferase, Total bilirubin, Total protein, Albumin, Alkaline phosphatase, Serum uric acid, Glucose, Triglycerides, Total cholesterol, High-density lipoprotein cholesterol, Low-density lipoprotein cholesterol
Measured: Up to Day 14
Incidence of Adverse events in terms of changes in Physical examinations
Review of body weight and height; general appearance; head; eyes; ears/nose/throat; neck; lymph nodes; neurological and musculoskeletal systems; heart; lungs; abdomen; skin; and extremities
Measured: Up to Day 14
Incidence of Adverse events in terms of changes in Vital signs
Oral temperature, respiratory rate, blood pressure, and pulse rate
Measured: Up to Day 14
Incidence of Adverse events in terms of changes in 12-lead ECGs
The 12-lead ECGs must be recorded after the subjects have rested in the supine position for 5 minutes to ensure a stable baseline.
Measured: Up to Day 14
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 Jul 2017
- Study start4 Jul 2017
- Primary completion15 Feb 2018
- Study completion15 Feb 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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atridia Pty Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sam Salman, B.Sc.BMBS, Principal investigator, Linear Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211403
- Sponsor's protocol ID
- SHR4640-102-AUS
- Status last verified
- Mar 2018
- First submitted
- 27 Jun 2017
- Last updated
- 21 Mar 2018
- 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 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of SHR4640 in Male Subjects With High Serum Uric Acid Level
- ClinicalTrials.gov ID
- NCT03211403
- Acronym / sponsor ID
- SHR4640-102-AUS
- Conditions
- Gout, Hyperuricemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Atridia Pty Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jul 2017 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 15 Feb 2018 (actual)
- First posted
- 7 Jul 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.
This is a single-Center, randomized, double-Blind, placebo-controlled, multiple ascending-dose Phase I trail.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SHR4640 2.5mg | Experimental | Drug: SHR46406 subjects assigned to 2.5mg SHR4640 and 2 subjects assigned to placebo |
| SHR4640 10mg | Experimental | Drug: SHR46406 subjects assigned to 10mg SHR4640 and 2 subjects assigned to placebo |
| SHR4640 20mg | Experimental | Drug: SHR46406 subjects assigned to 20mg SHR4640 and 2 subjects assigned to placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male, aged between 18 and 65 years, inclusive.
- Body weight ≥ 50 kg and body mass index between 18.0 and 35.0 kg/m2, inclusive.
- Screening sUA level ≥0.36 mmol/L.
- Considered generally healthy upon completion of medical history, full physical examination, vital signs, laboratory parameters (including thyroid function and serological tests, hematology, urinalysis, and biochemistry), 12-lead ECG, and abdominal ultrasound, as judged by the Investigator.
- Agrees to use a highly effective method of contraception, i.e. condom and suitable contraception for his female partner e.g. oral contraceptive or intrauterine contraceptive device during heterosexual intercourse or be non-heterosexually active, or practice sexual abstinence throughout the study period and for 30 days following final dose of study drug, and must agree to refrain from sperm donation from Day -2 until at least 30 days following final dose of study drug.
Key exclusion criteria (20 listed)
- History of hypersensitivity to SHR4640 or its analogues.
- History of gout.
- Screening alanine aminotransferase, aspartate aminotransferase, total bilirubin, or gamma glutamyl transferase > 1.5 × upper limit of normal.
- Positive result for human immunodeficiency virus (HIV).
- Positive result for hepatitis B surface antigen or hepatitis C virus antibody.
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 |
|---|---|---|
| SHR4640SHR4640 or placebo once daily for a week | Drug | SHR4640 10mg, SHR4640 2.5mg, SHR4640 20mg |
Primary outcome
Incidence of Adverse events in terms of changes in Hematology
Time frame: Up to Day 14
Hemoglobin Hematocrit Erythrocytes count Mean cell volume, Mean cell hemoglobin concentration, Leukocytes count, Neutrophils count, Lymphocytes count, Monocytes count, Eosinophils count, Basophils count, Platelets count
Incidence of Adverse events in terms of changes in Urinalysis
Time frame: Up to Day 14
Urobilinogen Dipstick urinalysis, including: pH, Specific gravity, Protein, Blood, Leukocytes, Glucose, Ketones, Bilirubin, Nitrites
Incidence of Adverse events in terms of changes in Biochemistry (fasting)
Time frame: Up to Day 14
Including Serum creatinine, Urea, Alanine aminotransferase, Aspartate aminotransferase, Gamma glutamyl transferase, Total bilirubin, Total protein, Albumin, Alkaline phosphatase, Serum uric acid, Glucose, Triglycerides, Total cholesterol, High-density lipoprotein cholesterol, Low-density lipoprotein cholesterol
Incidence of Adverse events in terms of changes in Physical examinations
Time frame: Up to Day 14
Review of body weight and height; general appearance; head; eyes; ears/nose/throat; neck; lymph nodes; neurological and musculoskeletal systems; heart; lungs; abdomen; skin; and extremities
Incidence of Adverse events in terms of changes in Vital signs
Time frame: Up to Day 14
Oral temperature, respiratory rate, blood pressure, and pulse rate
Incidence of Adverse events in terms of changes in 12-lead ECGs
Time frame: Up to Day 14
The 12-lead ECGs must be recorded after the subjects have rested in the supine position for 5 minutes to ensure a stable baseline.
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 21 Mar 2018.
- 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.
Sam Salman, B.Sc.BMBS principal investigator
Linear Clinical Research
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 and Hyperuricemia, run by Atridia Pty Ltd. at 1 site in Australia.
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 7 inclusion and 20 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 21 Mar 2018. 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 Australia. 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?
Incidence of Adverse events in terms of changes in Hematology (time frame: Up to Day 14). The study lists 6 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 21 Mar 2018.