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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03015948




Registration number
NCT03015948
Ethics application status
Date submitted
20/09/2016
Date registered
10/01/2017
Date last updated
3/07/2018

Titles & IDs
Public title
A Single Dose Study of SHR4640 in Healthy Male Volunteers
Scientific title
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Dose of SHR4640 in Healthy Male Volunteers
Secondary ID [1] 0 0
SHR4640-101-AUS
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 0 0
Condition category
Condition code

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

Experimental: 2.5mg SHR4640 - 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)

Experimental: 10mg SHR4640 - 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.

Experimental: 20mg SHR4640 - 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) .

Experimental: Placebo - 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)

Experimental: 5mg SHR4640 - 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)


Treatment: Drugs: SHR4640
a single dose of SHR4640 (n=8) for each dose cohort

Treatment: Drugs: Placebo
a single dose of placebo (n=2) for each dose cohort .
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
11 days
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
from time of dosing to 72 hours
Secondary outcome [2] 0 0
Assess Pharmacokinetics (PK) Plasma parameter Time to maximum concentration.
Timepoint [2] 0 0
from time of dosing to 72 hours
Secondary outcome [3] 0 0
Assess Pharmacokinetics (PK) Plasma parameter Maximum concentration.
Timepoint [3] 0 0
from time of dosing to 72 hours
Secondary outcome [4] 0 0
Assess Pharmacokinetics (PK) Plasma parameter Terminal elimination half-life (T1/2).
Timepoint [4] 0 0
from time of dosing to 72 hours
Secondary outcome [5] 0 0
Assess Pharmacodynamics (PD) parameter Actual and percent changes in serum uric acid (sUA )from baseline.
Timepoint [5] 0 0
from time of dosing to 72 hours
Secondary outcome [6] 0 0
Assess Pharmacodynamics (PD) parameter urinary uric acid concentration (uUA): actual and percent changes from baseline.
Timepoint [6] 0 0
from time of dosing to 72 hours
Secondary outcome [7] 0 0
Assess Pharmacodynamics (PD) parameter urinary uric acid excretion (eUA): actual and percent changes from baseline.
Timepoint [7] 0 0
from time of dosing to 72 hours
Secondary outcome [8] 0 0
Assess Pharmacodynamics (PD) parameter Uric acid renal clearance (UaCl): actual and percent changes from baseline
Timepoint [8] 0 0
from time of dosing to 72 hours

Eligibility
Key inclusion criteria
1. Male, aged between 18 and 55 years, inclusive.
2. Body weight = 50 kg and body mass index between 18.0 to 30.0 kg/m2, inclusive.
3. Screening sUA level from 0.24 to 0.42 mmol/L, inclusive.
4. 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.
5. 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.
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 written informed consent before any study-related activity.
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of hypersensitivity to SHR4640 or its analogues.
2. Screening sCr above upper limit of normal.
3. Screening alanine aminotransferase, aspartate aminotransferase, total bilirubin, or gamma glutamyl transferase > 1.5 × upper limit of normal.
4. Positive result for 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 in administering the trial product to the subject.
8. Undergone major surgery within 3 months of Day 1.
9. Donated any blood or plasma in the past month or more than 400 mL within 3 months of Day 1.
10. Has poor venous access and is unable to donate blood.
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 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).
15. Consumes grapefruit and/or poppy seed within 5 days of Day 1.
16. Cannot refrain from heavy exercises, tobacco products, alcohol, grapefruit, and/or poppy seed from Day -2 to Day 4.
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
22/09/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/11/2016
Sample size
Target
Accrual to date
Final
40
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, single ascending-dose Phase I trial.
Trial website
https://clinicaltrials.gov/study/NCT03015948
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/study/NCT03015948