GoutPhase 1NCT03015948
A Single Dose Study of SHR4640 in Healthy Male Volunteers
A Phase 1 study testing SHR4640 in people with Gout, run by Atridia Pty Ltd. at 1 site in Australia.
Trial summary
This is a single-center, randomized, double-blind, placebo-controlled, single ascending-dose Phase I trial. 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
- What is being tested?
- SHR4640
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- 22 Sep 2016to 23 Nov 2016
- 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
- Male, aged between 18 and 55 years, inclusive.
- Body weight ≥ 50 kg and body mass index between 18.0 to 30.0 kg/m2, inclusive.
- Screening sUA level from 0.24 to 0.42 mmol/L, inclusive.
- Considered generally healthy upon completion of medical history, full physical examination, vital signs, laboratory parameters (including thyroid function, coagulation and serological tests, hematology, creatinine kinase, biochemistry, and urinalysis), 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 your female partner e.g. diaphragm (double barrier), 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 study drug dosing, and must agree to refrain from sperm donation from Day -2 until at least 30 days following study drug dosing.
- 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 written informed consent before any study-related activity.
Who cannot join
- History of hypersensitivity to SHR4640 or its analogues.
- Screening sCr above upper limit of normal.
- Screening alanine aminotransferase, aspartate aminotransferase, total bilirubin, or gamma glutamyl transferase > 1.5 × upper limit of normal.
- Positive result for HIV.
- Positive result for hepatitis B surface antigen or hepatitis C virus antibody.
- History or presence of kidney stones.
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- Acute or chronic illness that, in the opinion of the Investigator, might confound the results of the trial or pose risk in administering the trial product to the subject.
- Undergone major surgery within 3 months of Day 1.
- Donated any blood or plasma in the past month or more than 400 mL within 3 months of Day 1.
- Has poor venous access and is unable to donate blood.
- 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 drinks of alcohol per week (eg, 1 drink = 5 oz [150 mL] of wine, 12 oz of beer, or 1.5 oz of hard liquor).
- Consumes grapefruit and/or poppy seed within 5 days of Day 1.
- Cannot refrain from heavy exercises, tobacco products, alcohol, grapefruit, and/or poppy seed from Day -2 to Day 4.
- 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 Single Dose of SHR4640 in Healthy Male Volunteers
This is a single-center, randomized, double-blind, placebo-controlled, single ascending-dose Phase I trial.
Read the detailed description
This study includes screening (Days -16 to -3), check-in (Day -2), enrollment (Day -1), dosing (Day 1), observational period (Days 2 to 3), discharge day (Day 4), and safety follow-up visit (Day 8). Forty eligible subjects will be enrolled into 4 dose cohorts (10 for each cohort), and every 10 subjects will be randomized in a 4:1 ratio to receive a single dose of either SHR4640 (n=8) or placebo (n=2).
- Conditions
- Gout
- Being tested
- SHR4640, Placebo
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR4640Drug
a single dose of SHR4640 (n=8) for each dose cohort
PlaceboDrug
a single dose of placebo (n=2) for each dose cohort .
| Study group | Role | What they receive |
|---|---|---|
| 2.5mg SHR4640 | Experimental | 10 subjects will be randomized in a 4:1 ratio to receive a single dose of either 2.5 mg SHR4640 (n=8) or placebo (n=2) Receives: Drug: SHR4640 |
| 10mg SHR4640 | Experimental | 10 subjects will be randomized in a 4:1 ratio to receive a single dose of either 10mg SHR4640 (n=8) or placebo (n=2) 10mg. Receives: Drug: SHR4640 |
| 20mg SHR4640 | Experimental | 10 subjects will be randomized in a 4:1 ratio to receive a single dose of either 20mg SHR4640 (n=8) or placebo (n=2) . Receives: Drug: SHR4640 |
| Placebo | Experimental | For each dose cohort, 10 subjects will be randomized in a 4:1 ratio to receive a single dose of either SHR4640 (n=8) or placebo (n=2) Receives: Drug: Placebo |
| 5mg SHR4640 | Experimental | 10 subjects will be randomized in a 4:1 ratio to receive a single dose of either 5 mg SHR4640 (n=8) or placebo (n=2) Receives: Drug: SHR4640 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess safety and tolerability of SHR 4640 over 11days including AEs, laboratory safety variables (including hematology, creatinine kinase (CK), biochemistry, and urinalysis), physical examinations, vital signs, and 12-lead electrocardiograms (ECGs)
Measured: 11 days
Secondary outcomes (8)
Assess Pharmacokinetics (PK) Plasma parameter Area under the concentration-time curve (AUC) from zero to 24 and 72 hours postdose and from zero to infinity.
Measured: from time of dosing to 72 hours
Assess Pharmacokinetics (PK) Plasma parameter Time to maximum concentration.
Measured: from time of dosing to 72 hours
Assess Pharmacokinetics (PK) Plasma parameter Maximum concentration.
Measured: from time of dosing to 72 hours
Assess Pharmacokinetics (PK) Plasma parameter Terminal elimination half-life (T1/2).
Measured: from time of dosing to 72 hours
Assess Pharmacodynamics (PD) parameter Actual and percent changes in serum uric acid (sUA )from baseline.
Measured: from time of dosing to 72 hours
Assess Pharmacodynamics (PD) parameter urinary uric acid concentration (uUA): actual and percent changes from baseline.
Measured: from time of dosing to 72 hours
Assess Pharmacodynamics (PD) parameter urinary uric acid excretion (eUA): actual and percent changes from baseline.
Measured: from time of dosing to 72 hours
Assess Pharmacodynamics (PD) parameter Uric acid renal clearance (UaCl): actual and percent changes from baseline
Measured: from time of dosing to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study start22 Sep 2016
- Primary completion23 Nov 2016
- Study completion23 Nov 2016
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
- 40 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
- NCT03015948
- Sponsor's protocol ID
- SHR4640-101-AUS
- Status last verified
- Jul 2018
- First submitted
- 20 Sep 2016
- Last updated
- 3 Jul 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 3 Jul 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 Single Dose of SHR4640 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03015948
- Acronym / sponsor ID
- SHR4640-101-AUS
- Conditions
- Gout
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Atridia Pty Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Sep 2016 (actual)
- Primary completion
- 23 Nov 2016 (actual)
- Study completion
- 23 Nov 2016 (actual)
- First posted
- 10 Jan 2017 (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.
This is a single-center, randomized, double-blind, placebo-controlled, single ascending-dose Phase I trial.
Detailed description
This study includes screening (Days -16 to -3), check-in (Day -2), enrollment (Day -1), dosing (Day 1), observational period (Days 2 to 3), discharge day (Day 4), and safety follow-up visit (Day 8). Forty eligible subjects will be enrolled into 4 dose cohorts (10 for each cohort), and every 10 subjects will be randomized in a 4:1 ratio to receive a single dose of either SHR4640 (n=8) or placebo (n=2).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 2.5mg SHR4640 | Experimental | Drug: SHR464010 subjects will be randomized in a 4:1 ratio to receive a single dose of either 2.5 mg SHR4640 (n=8) or placebo (n=2) |
| 10mg SHR4640 | Experimental | Drug: SHR464010 subjects will be randomized in a 4:1 ratio to receive a single dose of either 10mg SHR4640 (n=8) or placebo (n=2) 10mg. |
| 20mg SHR4640 | Experimental | Drug: SHR464010 subjects will be randomized in a 4:1 ratio to receive a single dose of either 20mg SHR4640 (n=8) or placebo (n=2) . |
| Placebo | Experimental | Drug: PlaceboFor each dose cohort, 10 subjects will be randomized in a 4:1 ratio to receive a single dose of either SHR4640 (n=8) or placebo (n=2) |
| 5mg SHR4640 | Experimental | Drug: SHR464010 subjects will be randomized in a 4:1 ratio to receive a single dose of either 5 mg SHR4640 (n=8) or placebo (n=2) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male, aged between 18 and 55 years, inclusive.
- Body weight ≥ 50 kg and body mass index between 18.0 to 30.0 kg/m2, inclusive.
- Screening sUA level from 0.24 to 0.42 mmol/L, inclusive.
- Considered generally healthy upon completion of medical history, full physical examination, vital signs, laboratory parameters (including thyroid function, coagulation and serological tests, hematology, creatinine kinase, biochemistry, and urinalysis), 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 your female partner e.g. diaphragm (double barrier), 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 study drug dosing, and must agree to refrain from sperm donation from Day -2 until at least 30 days following study drug dosing.
Key exclusion criteria (20 listed)
- History of hypersensitivity to SHR4640 or its analogues.
- Screening sCr above upper limit of normal.
- Screening alanine aminotransferase, aspartate aminotransferase, total bilirubin, or gamma glutamyl transferase > 1.5 × upper limit of normal.
- Positive result for 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 |
|---|---|---|
| SHR4640a single dose of SHR4640 (n=8) for each dose cohort | Drug | 10mg SHR4640, 2.5mg SHR4640, 20mg SHR4640, 5mg SHR4640 |
| Placeboa single dose of placebo (n=2) for each dose cohort . | Drug | Placebo |
Primary outcome
Assess safety and tolerability of SHR 4640 over 11days including AEs, laboratory safety variables (including hematology, creatinine kinase (CK), biochemistry, and urinalysis), physical examinations, vital signs, and 12-lead electrocardiograms (ECGs)
Time frame: 11 days
8 secondary outcomes
Assess Pharmacokinetics (PK) Plasma parameter Area under the concentration-time curve (AUC) from zero to 24 and 72 hours postdose and from zero to infinity.
Time frame: from time of dosing to 72 hours
Assess Pharmacokinetics (PK) Plasma parameter Time to maximum concentration.
Time frame: from time of dosing to 72 hours
Assess Pharmacokinetics (PK) Plasma parameter Maximum concentration.
Time frame: from time of dosing to 72 hours
Assess Pharmacokinetics (PK) Plasma parameter Terminal elimination half-life (T1/2).
Time frame: from time of dosing to 72 hours
Assess Pharmacodynamics (PD) parameter Actual and percent changes in serum uric acid (sUA )from baseline.
Time frame: from time of dosing to 72 hours
Assess Pharmacodynamics (PD) parameter urinary uric acid concentration (uUA): actual and percent changes from baseline.
Time frame: from time of dosing to 72 hours
Assess Pharmacodynamics (PD) parameter urinary uric acid excretion (eUA): actual and percent changes from baseline.
Time frame: from time of dosing to 72 hours
Assess Pharmacodynamics (PD) parameter Uric acid renal clearance (UaCl): actual and percent changes from baseline
Time frame: from time of dosing to 72 hours
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 3 Jul 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, 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 3 Jul 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?
Assess safety and tolerability of SHR 4640 over 11days including AEs, laboratory safety variables (including hematology, creatinine kinase (CK), biochemistry, and urinalysis), physical examinations, vital signs, and 12-lead electrocardiograms (ECGs) (time frame: 11 days). 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 3 Jul 2018.