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A Single Dose Study of SHR4640 in Healthy Male Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03015948
Recruitment Status : Completed
First Posted : January 10, 2017
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Atridia Pty Ltd.

Brief Summary:
This is a single-center, randomized, double-blind, placebo-controlled, single ascending-dose Phase I trial.

Condition or disease Intervention/treatment Phase
Gout Drug: SHR4640 Drug: Placebo Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Dose of SHR4640 in Healthy Male Volunteers
Actual Study Start Date : September 22, 2016
Actual Primary Completion Date : November 23, 2016
Actual Study Completion Date : November 23, 2016

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout

Arm Intervention/treatment
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)
Drug: SHR4640
a single dose of SHR4640 (n=8) for each dose cohort

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.
Drug: SHR4640
a single dose of SHR4640 (n=8) for each dose cohort

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) .
Drug: SHR4640
a single dose of SHR4640 (n=8) for each dose cohort

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)
Drug: Placebo
a single dose of placebo (n=2) for each dose cohort .

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




Primary Outcome Measures :
  1. 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 ]

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015948


Locations
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Australia, New South Wales
Atridia Pty Limited
Sydney, New South Wales, Australia, 2000
Sponsors and Collaborators
Atridia Pty Ltd.
Investigators
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Principal Investigator: Sam Salman, B.Sc,BMBS Linear Clinical Research
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Responsible Party: Atridia Pty Ltd.
ClinicalTrials.gov Identifier: NCT03015948    
Other Study ID Numbers: SHR4640-101-AUS
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No