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    Summary
    EudraCT Number:2008-005558-19
    Sponsor's Protocol Code Number:IDX-08C-003
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-12-17
    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 ConcernedAustria - BASG
    A.2EudraCT number2008-005558-19
    A.3Full title of the trial
    A Phase I/II, Double-Blind, Dose-Escalation Study to Evaluate the Safety and Antiviral Activity of IDX184 in Treatment-Naïve Subjects Infected with Genotype 1 Chronic Hepatitis C
    A.4.1Sponsor's protocol code numberIDX-08C-003
    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 nameIDX184
    D.3.2Product code IDX184
    D.3.4Pharmaceutical form Capsule*
    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 codeIDX184, IDX14184, NM108-SATE (S-acyl-2-thioethyl), IDX-08C
    D.3.9.3Other descriptive name2'-C-methyl nucleoside phosphoramidate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 placeboCapsule*
    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
    Naïve Subjects Infected with Genotype 1 Chronic Hepatitis C
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    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
    The primary objective is to investigate safety and tolerability.
    E.2.2Secondary objectives of the trial
    The secondary objective is to determine antiviral activity.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To participate in the study, subjects must meet all of the following inclusion criteria:
    1. Subject is 18-65 years of age, inclusive (or the legal age of consent per
    local regulations).
    2. Female subjects of both childbearing potential and non-childbearing
    potential may be included, unless the local regulatory authority
    requires that only females of non-childbearing potential be included.
    Non-childbearing potential is defined as one of the following:
    • Post-menopausal, defined as amenorrheic for at least 2 years
    and have a serum FSH level ≥ 40 IU/L at screening
    • Have had a documented hysterectomy, bilateral oophorectomy
    or bilateral tubal ligation at least 6 months prior to study initiation
    3. All female subjects of childbearing potential must have agreed to use a
    consistent form of an acceptable double-barrier method of birth control
    (such as a condom plus spermicide) from screening through at least
    30 days after the last dose of the study drug. All male subjects of
    childbearing potential must have agreed to use a consistent form of an
    acceptable double-barrier method of birth control (such as a condom
    plus spermicide) from first dose through at least 90 days after the last
    dose of the study drug.
    4. Male subjects must have agreed not to donate sperm from the first
    dose through 90 days after the last dose of study drug.
    5. Documented clinical history compatible with chronic hepatitis C,
    including presence of HCV RNA in the plasma at least six months
    prior to screening and liver biopsy within 24 months of screening or
    dosing with histology consistent with chronic hepatitis C infection.
    6. Plasma HCV RNA ≥ 5 log10 IU/mL at screening.
    7. HCV genotype 1 (no mixed genotypes), by HCV genotyping performed
    at screening.
    8. Pulse ≥ 45 BPM, systolic blood pressure ≥ 90 mmHg and QTc interval
    ≤ 430 ms for males or ≤ 450 ms for females, at screening and prior to
    dosing on Day 1.
    9. Subject is, in the opinion of the investigator, willing and able to comply
    with the study drug regimen and all other study requirements; subject
    has provided written informed consent to participate in the study.
    E.4Principal exclusion criteria
    Subjects will be excluded from the study if they meet any of the following exclusion criteria:
    1. Subject is pregnant or breastfeeding. Women must have a negative serum beta-human chorionic gonadotropin (β-HCG) at screening and a negative urine pregnancy test prior to the first dose of study medication on Day 1.
    2. Body Mass Index (BMI) > 32.
    3. Co-infected with hepatitis B virus (HBV, HBsAg positive) and/or human
    immunodeficiency virus (HIV).
    4. History or signs of decompensated liver disease: Child-Pugh class B or C, ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of portal hypertension or hepatic insufficiency.
    5. History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC, such as suspicious foci on imaging studies or elevated serum alpha-fetoprotein (AFP) level (>50 ng/mL). In subjects with such findings, HCC should be ruled-out prior to
    randomization.
    6. Has one or more additional known primary or secondary causes of liver disease, other than hepatitis C (e.g., alcoholism, autoimmune hepatitis, nonalcoholic steatohepatitis, drugrelated 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).
    7. Abnormal renal function as evidenced by a screening serum creatinine or BUN value > upper limit of normal or a screening creatinine clearance (CLCR) < 80 mL/min as estimated by the Cockcroft-Gault formula
    8. History of other clinically significant diseases including:
    • Acute liver or biliary injury due to drugs, ingested toxins (e.g. mushrooms), other
    viral hepatitis (e.g. hepatitis A), gallstones or other etiologies
    • Active malignant disease or suspicion or history of malignant disease within previous 5 years (except for adequately treated basal cell carcinoma)
    • History of organ transplants, except for corneal or hair transplant
    • Uncontrolled depressive illness
    • Uncontrolled hyperthyroidism or autoimmune thyroidopathy. Thyroid function
    (thyroid stimulating hormone (TSH), T4 and T3) must be normal at screening.
    • Uncontrolled hypertension
    • Type 1 diabetes mellitus or Type 2 diabetes being treated with oral hypoglycemic
    agents
    • Neurological disease
    • Acute or chronic pancreatitis
    • Active infections including tuberculosis or opportunistic infection
    • Intestinal malabsorption (e.g., structural defects, digestive failure, enzyme
    deficiencies, etc.)
    • Cardiac disease, clinically significant arrhythmia, family history of congenital heart
    disease, family history of prolonged QT, or family history of sudden death of
    unknown etiology
    • 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
    9. Currently abusing alcohol or illicit drugs, or unwilling to abstain from the use of alcohol from 72 hours prior to dosing through to the end of the study. For the purposes of this study, alcohol abuse is arbitrarily defined as frequent consumption of alcoholic beverages with an average daily intake of more than 40 g of ethanol.
    10. Received prior antiviral treatment for hepatitis C infection.
    11. Currently receiving methadone, buprenorphine or other drugs for the treatment of opioid addiction.
    12. Use of any known inhibitor and/or inducer of cytochrome P450 3A4 (CYP 3A4) within 30 days of dosing.
    13. Use of other investigational drugs within 30 days of dosing, or plans to enroll in another
    clinical trial of an investigational agent while participating in the present study.
    14. Clinically significant abnormal ECG at screening and prior to dosing on Day 1.
    15. Abnormal values at screening:
    • Hemoglobin (Hgb) < 12.0 g/dL for males, < 11.0 g/dL for females
    • absolute neutrophil count (ANC) < 1.5 x 10e9/L
    • platelets < 130 x 10e9/L
    • ALT or AST > 2.5x upper limit of normal (ULN)
    • alkaline phosphatase (ALP) > 1.25xULN
    • albumin < 3.5 g/dL
    • total bilirubin > ULN
    • amylase or lipase > ULN
    • prothrombin time ≥ 3 seconds prolonged despite vitamin K administration
    E.5 End points
    E.5.1Primary end point(s)
    Change in HCV RNA level from Day 1 to Day 4 (primary efficacy endpoint)
    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 Yes
    E.6.13.1Other scope of the trial description
    A descriptive analysis of treatment emergent mutations in the HCV polymerase gene will be conducted
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Dose escalation study (4 consecutive cohorts) each designed as described above
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Stopping rules are defined for both individual subjects and cohorts who experience significant events and are described in the protocol in section 4.1, section 7.5.1.1 referring to appendix 2.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 40
    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 Decision2009-03-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-01-10
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