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    Summary
    EudraCT Number:2009-018079-15
    Sponsor's Protocol Code Number:IDX-07A-001
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-01-26
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2009-018079-15
    A.3Full title of the trial
    A Phase I/IIa Study Assessing Single and Multiple Doses of HCV Protease Inhibitor IDX320 in Healthy and Genotype 1 HCV-Infected Subjects
    A.4.1Sponsor's protocol code numberIDX-07A-001
    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 SponsorIdenix Pharmaceuticals, 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 nameIDX320
    D.3.2Product code IDX320
    D.3.4Pharmaceutical form Tablet
    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.3.9.2Current sponsor codeIDX16320;IDX-07A
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Healthy Volunteers and Genotype 1 HCV infection
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10008912
    E.1.2Term Chronic hepatitis C
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - Safety and tolerability: adverse events, physic examination, vital signs, 1-lead ECG and standard safety laboratory tests.
    - Antiviral activity: change in plasma HCV RNA, emergence of resistance mutations.
    E.2.2Secondary objectives of the trial
    - Pharmacokinetics: plasma and urine PK of IDX320
    - Food effect
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.18-65 years of age, inclusive (or the legal age of consent per local regulations).
    2.Body Mass Index (BMI) 18-35 kg/m2
    3.Male subjects must have agreed to use a consistent form of an acceptable double-barrier method of birth control from first dose through at least 90 days after the last dose of the study drug.
    4.Subject must have agreed not to donate sperm from the first dose through 90 days after the last dose of study drug.
    5.Agrees not to consume grapefruit juice within 48 hours of reporting to the clinic on Day -1 through the end of the study.
    6.Pulse ≥ 40 BPM, systolic blood pressure ≥ 95 mmHg and QTcF interval ≤ 450 ms at screening and Day -1.
    7.Subject is, in the opinion of the investigator, willing and able to comply with the study drug regimen and all other study requirements.
    8.Subject has provided written informed consent to participate in the study.
    Part A Specific (must also meet the following)
    9.Subject must be male.

    Part C and D Specific (must also meet the following)
    10.HCV treatment-naïve – subject must have not received prior antiviral treatment for hepatitis C infection.

    Parts B, C and D Specific (must also meet the following)
    11.Male or female subjects may be included. If female, subject must be of non-childbearing potential. Non-childbearing potential is defined as one of the following:
    •Post-menopausal, defined as amenorrheic for at least 2 years and serum FSH level ≥ 27 IU/L at screening.
    •A documented hysterectomy, bilateral oophorectomy or bilateral tubal ligation at least 6 months prior to study initiation.
    12. Documented clinical history compatible with chronic hepatitis C, including any one of the following:
    •anti-HCV antibody positive at least six months prior to screening or dosing OR
    •HCV RNA present in plasma by a sensitive and specific assay at least six months prior to screening or dosing OR
    •Histologic evidence of chronic hepatitis C infection (Note: Subjects with cirrhosis are excluded, see exclusion #19.)
    13.Plasma HCV RNA ≥ 5 log10 IU/mL at screening.
    14.HCV genotype 1 by HCV genotyping performed at screening.
    E.4Principal exclusion criteria
    1.Co-infected with hepatitis B virus (HBV, HBsAg positive) and/or human immunodeficiency virus (HIV).
    2.Donated blood or had significant blood loss 60 days prior to dosing.
    3.Use of alcohol and/or drugs that could interfere with adherence to study requirements as judged by the investigator. This includes drugs given for therapeutic reasons.
    4.Positive screen result for drugs of abuse (except THC) or alcohol on Day –1.
    5.Concomitant use of any known major inhibitor or inducer of cytochrome P450 3A4 (CYP 3A4). A washout period of at least 5 half-lives of the CYP 3A4 drug must be observed prior to study drug dosing, if the investigator feels that the drug can be safely discontinued or substituted for the duration of the study.
    6.Use of other investigational drugs within 60 days of dosing, or plans to enroll in another clinical trial of an investigational agent while participating in the present study.
    7.Subject with intestinal malabsorption (e.g., structural defects, digestive failure or enzyme deficiencies with the exception of lactose intolerance).
    8.Subject with known allergy to the study medication or any of its components.
    9.Clinically significant abnormal ECG at screening or Day -1.
    10.Serum creatinine > ULN
    11.Estimated glomerular filtration rate (GFR) < 60 mL/min/1.73 m2 as estimated by the MDRD formula.

    PART A Specific (following also excluded)
    12.History of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to admission to the Clinical Unit OR history of smoking within 24 hours prior to admission to the Clinical Unit.
    13.Any clinically significant medical condition that, in the opinion of the Principal Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
    14.Concomitant use of prescription medications or systemic over-the-counter (OTC) medications. A washout period of at least 5 half-lives must be observed prior to study drug dosing, if the investigator feels that the medication can be safely discontinued for the duration of the study.
    15.Abnormal laboratory values at screening or Day -1 that are considered to be clinically significant by the Principal Investigator(s).
    16.Positive screen for anti-HCV antibody.

    PART B Specific (following also excluded)
    17.Subject received pegylated interferon and ribavirin within 6 months of screening.
    PART B, C and D Specific (following also excluded)
    18.Subject is pregnant or breastfeeding. Women must have a negative serum beta-human chorionic gonadotropin (β-HCG) at screening and Day -1.
    19.History or signs of decompensated liver disease: Child-Pugh class B or C (see Appendix 3), ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of portal hypertension or hepatic insufficiency.
    20.Prior clinical or histological evidence of cirrhosis (e.g. Metavir 4 or Ishak 6).
    21.History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC.
    22.Active clinically significant diseases including:
    •Primary or secondary causes of liver disease (other than hepatitis C). For example, alcoholism, autoimmune hepatitis, nonalcoholic steatohepatitis, drug-related liver disease, malignancy with hepatic involvement, hemochromatosis, alpha-1 antitrypsin deficiency, Wilson’s Disease, Gilbert’s syndrome, Dubin-Johnson syndrome, other congenital or metabolic conditions affecting the liver, etc.
    •Malignant disease or suspicion or history of malignant disease within previous 5 years (except for adequately treated basal cell carcinoma)
    •Diabetes mellitus requiring treatment with medication
    •Any other condition that, in the opinion of the Principal Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
    E.5 End points
    E.5.1Primary end point(s)
    - Safety: adverse events, physical examination, vital signs, laboratory evaluations, ECG, GFR.
    - Pharmacokinetics: plasma IDX320 concentration, urine IDX320 concentration, PK parameter.
    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 Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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 Yes
    E.8.1.1Randomised Yes
    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 Yes
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Last visit last subject as indicated per protocol.
    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 months9
    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 months9
    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) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 84
    F.4.2.2In the whole clinical trial 84
    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)
    not applicable
    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 Decision2010-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-04-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-08-30
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