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    Summary
    EudraCT Number:2013-004043-23
    Sponsor's Protocol Code Number:IDX-04B-001
    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:2013-10-03
    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 number2013-004043-23
    A.3Full title of the trial
    A Phase I/IIa Study Assessing Single and Multiple Doses of IDX21437 in Healthy and HCV-Infected Subjects
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A first-in-human trial of IDX21437, a new study drug being evaluated for hepatitis C virus infection.
    A.4.1Sponsor's protocol code numberIDX-04B-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01974687
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1149-5611
    A.7Trial is part of a Paediatric Investigation Plan No
    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 sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIdenix Pharmaceuticals Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIdenix Pharmaceuticals Inc.
    B.5.2Functional name of contact pointJohn Sullivan-Bolyai
    B.5.3 Address:
    B.5.3.1Street Address320 Bent Street, 4th Floor
    B.5.3.2Town/ cityCambridge, MA
    B.5.3.3Post code02141
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 877 433-6491
    B.5.5Fax number+1-617 995-9801
    B.5.6E-mailclinicaltrials@idenix.com
    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.3.2Product code IDX21437
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNto be determined
    D.3.9.2Current sponsor codeIDX21437
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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.IMP: 2
    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.3.2Product code IDX21437
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNto be determined
    D.3.9.2Current sponsor codeIDX21437
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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.IMP: 3
    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.3.2Product code IDX21437
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNto be determined
    D.3.9.2Current sponsor codeIDX21437
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    Hepatitis C virus
    E.1.1.1Medical condition in easily understood language
    Hepatitis C virus infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10019751
    E.1.2Term Hepatitis C virus
    E.1.2System Organ Class 100000004848
    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
    • Plasma and urine pharmacokinetics (PK)
    • The effect of food on the PK of IDX21437
    • Antiviral activity
    E.2.2Secondary objectives of the trial
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Read and signed the written informed consent form (ICF) after the nature of the study has been fully explained.
    2. Male or female subjects between 18 and 65 years of age, inclusive (or the legal age of consent per local regulations).
    3. Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg/m2 (Group A) or 18-35 kg/m2 (Groups B-E), inclusive.
    4. All subjects of childbearing potential must have agreed to use a double-method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of the study drug.
    Non-childbearing potential is defined as:
    • Females: postmenopausal, defined as amenorrheic for at least 2 years and serum follicle stimulating hormone (FSH) level consistent with postmenopausal status at Screening, or a self-reported hysterectomy, bilateral oophorectomy or bilateral tubal ligation at least 6 months prior to Screening.
    • Males: a self-reported vasectomy at least 6 months prior to Screening.
    5. Females must have a negative serum beta-human chorionic gonadotropin (β-HCG) at Screening and a negative pregnancy test (urine or β-HCG) at Day -1.
    6. Male subjects must have agreed not to donate sperm from the first dose through 90 days after the last dose of study drug.
    7. Subject must not have consumed grapefruit or grapefruit juice within 7 days of reporting to the clinic on Day -1, and agrees not to do so through the end of the study.
    8. Subject is, in the opinion of the investigator, willing and able to comply with the study drug regimen and all other study requirements.
    Group A Specific (must also meet the following)
    9. Subject must not have smoked or used nicotine-containing products within 6 months prior to Day -1 and agrees not to do so for the duration of the study.
    Groups B, C, D and E Specific (must also meet the following)
    10. Subjects in Group B may have received prior treatment with interferon (IFN) and ribavirin for hepatitis C infection but not treatment with any direct-acting antivirals (DAA). Subjects in Groups C, D and E must be HCV treatment-naïve (i.e., no prior exposure to any antiviral treatment for hepatitis C infection).
    11. Documented clinical history compatible with chronic hepatitis C, including any one of the following:
    • anti- HCV antibody positive at least 6 months prior to Screening or dosing, OR
    • HCV genotype results at least 6 months prior to Screening or dosing, OR
    • HCV RNA present in plasma by a sensitive and specific assay at least 6 months prior to Screening or dosing, OR
    • Histologic evidence of chronic hepatitis C infection
    12. HCV Genotype 1, 2, 3, 4, 5 or 6 by HCV genotyping performed at Screening (genotype dependent on the group/cohort enrolling). Note: For a specific genotype, mixed subtypes are acceptable but mixed genotypes are not.
    13. Plasma HCV RNA ≥ 5.0 log10 IU/mL at Screening.
    Group E Specific (must also meet the following)
    14. Subjects must be Child-Pugh Class A.
    E.4Principal exclusion criteria
    1.Female subject is pregnant or breastfeeding.
    2. Co-infected with hepatitis B virus (HBV, HBsAg positive) and/or human immunodeficiency virus (HIV).
    3. Donated more than 500 mL of blood or had significant blood loss 60 days prior to dosing.
    4.Abuse of alcohol and/or drugs that could interfere with adherence to study requirements as judged by the investigator.
    5.Positive screen result for drugs of abuse or alcohol at Screening or on Day –1.
    6.Concomitant use of any known major inhibitor or inducer of cytochrome P450 (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.
    7.Concomitant use of herbal or dietary supplements. A washout period of at least 7 days must be observed prior to study drug dosing.
    8.Concomitant use of acid blockers (e.g., proton-pump inhibitors). A washout period of at least 5 half-lives 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. Antacids (stomach acid neutralizers such as calcium carbonate or aluminum hydroxide-based products) will be allowed during the study, except ±4 h of dosing.
    9.Concomitant use of the following medications: amlodipine, aripiprazole, atorvastatin, carvedilol, diazepam, diltiazem, fluoxetine, isradipine, perphenazine, procainamide, simvastatin, thioridazine or verapamil. A washout period of at least 5 half-lives must be observed prior to initiating study drug dosing, if the investigator feels that the drug can be safely discontinued or substituted for the duration of the study.
    10.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.
    11.Subject with intestinal malabsorption (e.g., structural defects, digestive failure or enzyme deficiencies with the exception of lactose intolerance).
    12.Subject with known allergy to the study medication or any of its components.
    13.Cardiac disease, family history of congenital heart disease, family history of prolonged QT, or family history of sudden death of unknown etiology.
    14.One or more of the following abnormalities:
    •First degree, or greater, heart block.
    •QTcF interval ≥ 430 ms for males or ≥ 450 ms for females, at Screening, Day -1 and Day 1 (prior to the first dose).
    •Clinically significant abnormal ECG at Screening or Day -1, as determined by the investigator.
    15.At Screening or Day -1: an estimated glomerular filtration rate (GFR) < 60 mL/min/1.73 m2 as estimated by the Modification of Diet in Renal Disease (MDRD) formula.
    16.Hemoglobin (Hgb) < 13.0 g/dL for males, < 12.0 g/dL for females.
    17.Any clinically significant medical condition that, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results.
    Group A Specific (following also excluded)
    18.Concomitant use of prescription medications, or systemic over-the-counter 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.
    19.Abnormal laboratory values at Screening or Day -1 that are considered to be clinically significant by the investigator(s).
    20.Positive screen for HCV antibody.
    Groups B, C and D Specific (following also excluded)
    21.Clinical (in the opinion of the investigator) or laboratory evidence of cirrhosis (e.g., Metavir 4 or Ishak 6).
    Groups B, C, D and E Specific (following also excluded)
    22.History or signs of decompensated liver disease: ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of portal hypertension or hepatic insufficiency.
    23.History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC.
    24.Active clinically significant diseases including:
    •Primary or secondary causes of liver disease (other than hepatitis C).
    •Malignant disease or suspicion or history of malignant disease within previous 5 years (except for adequately treated basal cell carcinoma).
    •Poorly controlled diabetes mellitus as evidenced by hemoglobin A1c ≥ 8.5% at Screening.
    25.Requires frequent or prolonged use of systemic corticosteroids or other immunosuppressive drugs (e.g., for organ transplantation or autoimmune conditions). Topical or inhaled corticosteroids are permitted.
    26.Abnormal values at Screening or Day -1:
    •ALT or AST > 5 x upper limit of normal (ULN)
    •platelet count < 120 x 109/L
    •Any other laboratory abnormality that is considered to be clinically significant by the investigator(s)
    E.5 End points
    E.5.1Primary end point(s)
    plasma PK samples
    urine PK samples
    E.5.1.1Timepoint(s) of evaluation of this end point
    see protocol Tables 7-4, 7-5 & 7-6
    E.5.2Secondary end point(s)
    PK endpoints=plasma and urine concentrations of IDX21437 and metabolites

    Safety endpoints=adverse events and laboratory abnormalities

    Antiviral activity endpoints=change in HCV RNA viral load
    E.5.2.1Timepoint(s) of evaluation of this end point
    see Tables 7-1 through 7-6.
    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 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
    tolerability, food effect, anti-viral activity
    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 Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    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.8.2.4Number of treatment arms in the trial19
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    New Zealand
    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
    LVLS
    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 months8
    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 months8
    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.1.2.1Number of subjects for this age range: 132
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 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 state136
    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 Decision2013-10-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-13
    P. End of Trial
    P.End of Trial StatusCompleted
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