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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03211403




Registration number
NCT03211403
Ethics application status
Date submitted
27/06/2017
Date registered
7/07/2017
Date last updated
21/03/2018

Titles & IDs
Public title
Multiple Doses Study of SHR4640 in Male Subjects With High Serum Uric Acid Level
Scientific 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
Secondary ID [1] 0 0
SHR4640-102-AUS
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 0 0
Hyperuricemia 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Metabolic and Endocrine 0 0 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SHR4640

Experimental: SHR4640 2.5mg - 6 subjects assigned to 2.5mg SHR4640 and 2 subjects assigned to placebo

Experimental: SHR4640 10mg - 6 subjects assigned to 10mg SHR4640 and 2 subjects assigned to placebo

Experimental: SHR4640 20mg - 6 subjects assigned to 20mg SHR4640 and 2 subjects assigned to placebo


Treatment: Drugs: SHR4640
SHR4640 or placebo once daily for a week
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Adverse events in terms of changes in Hematology
Timepoint [1] 0 0
Up to Day 14
Primary outcome [2] 0 0
Incidence of Adverse events in terms of changes in Urinalysis
Timepoint [2] 0 0
Up to Day 14
Primary outcome [3] 0 0
Incidence of Adverse events in terms of changes in Biochemistry (fasting)
Timepoint [3] 0 0
Up to Day 14
Primary outcome [4] 0 0
Incidence of Adverse events in terms of changes in Physical examinations
Timepoint [4] 0 0
Up to Day 14
Primary outcome [5] 0 0
Incidence of Adverse events in terms of changes in Vital signs
Timepoint [5] 0 0
Up to Day 14
Primary outcome [6] 0 0
Incidence of Adverse events in terms of changes in 12-lead ECGs
Timepoint [6] 0 0
Up to Day 14
Secondary outcome [1] 0 0
Peak Plasma Concentration (Cmax) (of single dose and at stable status)
Timepoint [1] 0 0
Up to Day 10
Secondary outcome [2] 0 0
Area under the plasma concentration versus time curve (AUC) (of single dose and at stable status)
Timepoint [2] 0 0
Up to Day 10
Secondary outcome [3] 0 0
Half-time (T1/2) (of single dose and at stable status)
Timepoint [3] 0 0
Up to Day 10
Secondary outcome [4] 0 0
Time to the peak plasma concentration (Tmax) (of single dose and at stable status)
Timepoint [4] 0 0
Up to Day 10
Secondary outcome [5] 0 0
Changes in serum uric acid concentration from baseline
Timepoint [5] 0 0
Up to Day 10
Secondary outcome [6] 0 0
Changes in urinary uric acid excretion from baseline
Timepoint [6] 0 0
Up to Day 10

Eligibility
Key inclusion criteria
1. Male, aged between 18 and 65 years, inclusive.

2. Body weight = 50 kg and body mass index between 18.0 and 35.0 kg/m2, inclusive.

3. Screening sUA level =0.36 mmol/L.

4. 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.

5. 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.

6. Negative drug screen (including alcohol) at screening and on admission to clinical
site.

7. 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of hypersensitivity to SHR4640 or its analogues.

2. History of gout.

3. Screening alanine aminotransferase, aspartate aminotransferase, total bilirubin, or
gamma glutamyl transferase > 1.5 × upper limit of normal.

4. Positive result for human immunodeficiency virus (HIV).

5. Positive result for hepatitis B surface antigen or hepatitis C virus antibody.

6. History or presence of kidney stones.

7. 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.

8. Undergone major surgery within 3 months of Day 1 or has surgery planned during study
participation.

9. Donated any blood or plasma in the past month or more than 400 mL within 3 months of
Day 1.

10. Has unsuitable venous for blood sampling.

11. Use of tobacco products within 30 days of Day 1.

12. Heavy caffeine drinker (more than 5 cups or glasses of caffeinated beverages per day).

13. History of drug and/or alcohol abuse in the last year.

14. 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).

15. Consumes grapefruit and/or poppy seed within 5 days of Day 1.

16. Unable to refrain from strenuous exercises, tobacco products, alcohol, grapefruit,
and/or poppy seed from Day -2 to Day 10.

17. 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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/02/2018
Sample size
Target
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Atridia Pty Limited - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Atridia Pty Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a single-Center, randomized, double-Blind, placebo-controlled, multiple
ascending-dose Phase I trail.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03211403
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sam Salman, B.Sc.BMBS
Address 0 0
Linear Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03211403