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    Summary
    EudraCT Number:2009-014762-26
    Sponsor's Protocol Code Number:RDEA594-204
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-09-15
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2009-014762-26
    A.3Full title of the trial
    A Phase 2, Multiple-Dose, Pharmacokinetic and Pharmacodynamic Study of RDEA594 in Gout Patients with Hyperuricemia and Gout with Renal Insufficiency
    A.3.2Name or abbreviated title of the trial where available
    RDEA594 Renal Impairment in Patients with Hyperuricemia and Gout
    A.4.1Sponsor's protocol code numberRDEA594-204
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorArdea Biosciences, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRDEA594
    D.3.2Product code RDEA594
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1151516-14-1
    D.3.9.2Current sponsor codeRDEA594
    D.3.9.3Other descriptive nameRDEA594 Sodium
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Gout.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10018627
    E.1.2Term Gout
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the safety profile of orally administered RDEA594 alone or as an add-on to ongoing allopurinol treatment in gout patients with moderate renal insufficiency.
    E.2.2Secondary objectives of the trial
    •To evaluate the pharmacokinetics of RDEA594 in gout patients with moderate renal insufficiency.
    •To evaluate the pharmacokinetic interaction between RDEA594 and allopurinol/oxypurinol and between RDEA594 and colchicine in gout patients with moderate renal insufficiency.
    •To evaluate the uricosuric effects of orally administered RDEA594 alone or as an add-on to ongoing allopurinol treatment in gout patients with moderate renal insufficiency.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Subject is an adult male or non-reproductive (post-menopausal or surgically sterile) female. Postmenopausal is generally defined as a period of twelve (12) consecutive months of amenorrhoea. In women under 55 years of age whose menopausal status is in question, a follicle-stimulating hormone (FSH) level of >40 mIU/mL or an oestrogen deficiency of < 30 pg/m or a negative oestrogen test can confirm they are postmenopausal.
    2.Subject is ≥ 18 and ≤ 80 years of age at the time of day 1 study drug dosing
    3.Subject has a body mass index (BMI) ≥ 18 and ≤ 38 kg/m2, and weighs at least 50 kg (110 lbs)
    4.Subject meets one or more of the 1977 American Rheumatism Association (ARA) criteria for the diagnosis of acute arthritis of primary gout
    5.Subject has moderate renal impairment with an estimated creatinine clearance as determined by the Modification of Diet in Renal Disease (MDRD) method at screening that is ≥ 30 mL/min to < 60 mL/min. [Creatinine clearance determined MDRD method: CrCl (mL/min/1.73 m2) = 175 x (serum creatinine)-1.154 × (age)-0.203 x [1.212 if Black] x [0.742 if female]]. Subjects with age-related renal impairment may be included in addition to those with underlying renal disease.
    6.Subject has a screening serum urate (sUA) level ≥ 7 mg/dL for Cohort 1 and ≥ 6 mg/dL for Cohort 2, unless a lower sUA is agreed to by the Sponsor’s Medical Monitor.
    7.For Cohort 1, subject is not receiving urate lowering therapy for at least one month prior to the screening visit. For Cohort 2, subject is receiving a stable dose of allopurinol of 100 to 200 mg once daily for at least one month prior to the screening visit and dosage should remain unchanged for the duration of the study.
    8.Subject has a clinically acceptable physical examination with respect to the subject’s degree of renal impairment.
    9.Subject is free of any clinically significant disease that would interfere with study evaluations or procedures.
    10.Subject is informed of the nature of the study and has agreed to and is able to read, review and sign the informed consent document prior to any study related activities.
    E.4Principal exclusion criteria
    1. Subject requires dialysis for treatment of renal disease.
    2.Subject has a gout flare at screening that is resolved for less than one week prior to the first administration of study drug (exclusive of chronic synovitis/arthritis).
    3.Subject has documented history of, or suspicion of kidney stones.
    4.Subject has received any investigational drug within 2 months prior to study drug dosing.
    5.Subject has received a strong or moderate inhibitor of CYP3A4 or a P-gp inhibitor within 1 month prior to study drug dosing due to potential interactions with colchicine.
    6.Subject reports receiving any enzyme-inducing drug or product within 2 months prior to study drug dosing.
    7.Subject has uncontrolled hypertension, a clinically relevant abnormality in blood pressure (BP), heart rate (HR), body temperature, or respiratory rate as per the Investigator’s judgment as follows:
    a.Systolic BP < 90 mmHg and > 190 mmHg in supine position
    b.Diastolic BP < 45 mmHg and > 110 mmHg in supine position
    c.Heart rate < 40 bpm and > 100 bpm in supine position
    d.Body temperature < 35.0°C and > 37.5°C
    e.Respiratory rate < 8 bpm and > 20 bpm
    8.Subject has used medications that prolong the QT/QTc interval within 14 days prior to Day 1 dosing
    9.Subject has a history of clinically significant health problems or diseases unrelated to the patient’s renal insufficiency as determined by the clinical investigator(s). Patients with disorders related to renal insufficiency may be enrolled if in the investigator’s judgment the disorder will not compromise patient safety or study objectives
    10.Subject has a serum ALT or AST that exceeds 2.5 times the upper limit of normal.
    11.Subject has presence or history of cardiac abnormalities including abnormal and clinically relevant ECG changes such as bradycardia (sinus rate < 40 bpm), complete Left Bundle Branch Block (LBBB), second or third degree heart block, intraventricular conduction delay with QRS duration >140 milliseconds (msec), symptomatic arrhythmias, heart failure, hypokalemia, family history of Long QT Syndrome, family history of sudden death in otherwise healthy individual between the ages of 1 and 30 years
    12.Subject has a QTcB interval (QT interval corrected for heart rate according to Bazett) > 470 msec for males and > 490 msec for females at Screening, on Day –1 or pre-dose on Day 1.
    13.Subject has undergone major surgery within 3 months of Day 1.
    14.Subject has a confirmed reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody. Positive hepatitis C antibody to be confirmed by PCR.
    15.Subject has uncontrolled Diabetes Mellitus, metabolic syndrome, or chronic diarrhea.
    16.Subject has a clinically significant illness during the 7 days prior to day 1 study drug dosing (as determined by the clinical investigator)
    17.Subject demonstrates a positive drug screen (cocaine, cannabis, amphetamine, opiate) or alcohol screen at screening or check-in (Day -1), with the exception of prescription drugs
    18.Subject has a known hypersensitivity or allergy to RDEA594, allopurinol, colchicine, or any components in their formulations
    19.Subject has a history of clinically significant allergies including food or drug allergies
    20.Subject reports a history (within the past 12 months) or presence of drug addiction or excessive use of alcohol (weekly intake in excess of 28 units of alcohol; one unit of alcohol equals ½ a pint of beer or lager, a glass of wine or a measure of spirits)
    21.Subject has donated blood or experienced a significant blood loss (>450 mL) within 8 weeks prior to Day 1 or who have given a plasma donation within 4 weeks prior to the screening visit, and must be willing to avoid donating blood until 90 days after discharge from the study center
    22.Subject has an intolerance of repeated venipuncture
    23.Subject reports smoking more than 10 cigarettes per day
    24.Subject reports heavy caffeine consumption (> 5 cups or glasses of caffeinated beverages per day, e.g. coffee, tea or soda)
    E.5 End points
    E.5.1Primary end point(s)
    To determine the safety profile of orally administered RDEA594 alone or as an add-on to ongoing allopurinol treatment in gout patients with moderate renal insufficiency.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Normal treatment.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-10-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-26
    P. End of Trial
    P.End of Trial StatusCompleted
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