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    Summary
    EudraCT Number:2010-021156-26
    Sponsor's Protocol Code Number:VX10-950-022
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2012-02-17
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2010-021156-26
    A.3Full title of the trial
    A Phase 1, Randomized, Open-label, Single-Dose, Crossover, Relative Bioavailability, and Food-Effect Study of a Pediatric Chewable Tablet Formulation Relative to a 375-mg Core Tablet Formulation of Telaprevir in Healthy Adult Subjects
    A.4.1Sponsor's protocol code numberVX10-950-022
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/127/2008
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorVertex 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 supportVertex Pharmaceuticals Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVertex Pharmaceuticals Incorporated
    B.5.2Functional name of contact pointCentral Contact Center
    B.5.3 Address:
    B.5.3.1Street Address130 Waverly Street
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18776348789
    B.5.6E-mailmedicalinfo@vrtx.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.3.1Product nametelaprevir
    D.3.2Product code VX-950
    D.3.4Pharmaceutical form Tablet
    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 INNtelaprevir
    D.3.9.1CAS number 402957-28-2
    D.3.9.2Current sponsor codeVX-950
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number375
    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.3.1Product nametelaprevir
    D.3.2Product code VX-950
    D.3.4Pharmaceutical form Chewable tablet
    D.3.4.1Specific paediatric formulation Yes
    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 INNtelaprevir
    D.3.9.1CAS number 402957-28-2
    D.3.9.2Current sponsor codeVX-950
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    chronic hepatitis c virus genotype 1 infection
    E.1.1.1Medical condition in easily understood language
    chronic hepatitis c virus genotype 1 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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10008912
    E.1.2Term Chronic hepatitis C
    E.1.2System Organ Class 10021881 - Infections and infestations
    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 bioavailability of telaprevir administered as a pediatric chewable tablet formulation relative to a 375-mg core tablet formulation in the fed state
    - To evaluate the effect of food on the pharmacokinetics of telaprevir administered as a pediatric chewable tablet formulation
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of a single dose of telaprevir when administered to healthy adult subjects in the fed and fasted states
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects must be able to read, understand, sign the ICF, abide by the study requirements (e.g., comply with schedule visits, treatment regimen, laboratory tests, and other study procedures), and willing to complete the study as planned
    2. Subjects must be healthy males and/or females of non-childbearing potential aged 18 to 65 years, inclusive. Healthy is defined as having no clinically relevant abnormalities identified by a detailed medical history and full physical examination (including blood
    pressure, pulse rate measurement, 12-lead ECGs, and clinical laboratory tests) at the Screening Visit. Non-childbearing potential is defined in Section 12.6.6.
    3. Subjects with a body mass index (BMI) of 18 to 30 kg/m2 and weigh >50 kg at the Screening Visit. Only 3 subjects with a BMI greater than 29 kg/m2 will be enrolled in this study.
    E.4Principal exclusion criteria
    1. Subjects with a positive test result for any of the following infectious diseases:
    hepatitis A infection (confirmed by hepatitis A antibody IgM), hepatitis B antigen (HBsAG), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus 1 and
    2 antibodies (HIV 1 Ab or HIV 2 Ab)
    2. Subjects with a history of any illness that, in the opinion of the investigator or the subject’s general practitioner, might confound the results of the study or pose an additional risk in administering study drug to the subject. This may include, but is not limited to, a history of (1) relevant drug or food allergies; (2) cardiovascular or central nervous system disease; (3) clinically significant pathology (history or presence);
    (4) mental disease; or (5) chronic skin disease.
    3. Subjects with a history of febrile illness within 5 days prior to the first dose of study drug
    4. Subjects with any condition that may possibly affect drug absorption (e.g., gastrectomy, cholecystectomy, or other gastrointestinal track surgery, except appendectomy)
    5. Subjects with a positive urine screen result for drugs of abuse (Table 12-2)
    6. Subjects with a history of regular alcohol consumption exceeding 7 drinks/week for female subjects of non-childbearing potential or 14 drinks/week for male subjects, where 1 drink = 5 ounces (150 mL) of wine, 12 ounces (360 mL) of beer, or 1.5 ounces (45 mL) of hard liquor within 6 months of the Screening Visit
    7. Subjects treated with an investigational drug within 30 days (or as determined by the local requirements, whichever is longer) or 5 half-lives preceding the first dose of study drug
    8. Subjects with 12-lead ECG demonstrating QTc >450 msec at the Screening Visit. If the QTc exceeds 450 msec, then the ECG should be repeated 2 more times and the average of the 3 QTc values should be used to determine the subject’s eligibility
    9. Subjects who use prescription and/or nonprescription drugs within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study drug.
    10. Subjects who use vitamins and/or dietary supplements within 7 days before the first dose of study drug. Herbal supplements must be discontinued 14 days prior to the first dose of study drug.
    11. Hormone replacement therapy must be discontinued 28 days prior to the first dose of study drug. Depo-Provera must be discontinued at least 6 months prior to the first dose of study drug. As an exception, acetaminophen/paracetamol may be used at doses of
    ≤1g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by Vertex Pharmaceuticals Incorporated (Vertex).
    12. Subjects who have made a blood donation of approximately 1 pint (500 mL) within 56 days prior to the first dose of study drug
    13. Subjects who are unwilling or unable to comply with the Lifestyle Guidelines, as described in Section 10.3
    14. Subjects who are an investigator, sub-investigator, research assistant, pharmacist, study coordinator, staff, or a relative of study personnel directly involved with the conduct of the study
    15. Subjects who consume an average of more than five 8-ounce servings of coffee or other caffeinated beverage or seven 8-ounce servings of cola per day up to 72 hours before the first dose of study drug
    16. Subjects who have a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days of the last dose of study drug
    17. Subjects who have tobacco or nicotine-containing products use habit within 6 months before the Screening Visit
    E.5 End points
    E.5.1Primary end point(s)
    Pharmacokinetic exposure measurements, including maximum observed concentration (Cmax), area under the plasma concentration-time curve (AUC) from time 0h extrapolated to infinity (AUC∞), and AUC from time 0h to the last time point with a concentration above the lower limit of quantification or the last sampling time in a steady-state dosing interval (AUCtlast)
    E.5.2Secondary end point(s)
    - Time to reach Cmax after dosing (time of maximum concentration, tmax) and terminal half-life (t1/2)
    - Safety and tolerability as assessed by adverse events and changes in laboratory test values (chemistry and hematology), vital signs, 12-lead electrocardiograms (ECGs), and physical examinations
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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
    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) No
    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 No
    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 Will this trial be conducted at a single site globally? Yes
    E.8.4 Will this trial be conducted at multiple sites globally? No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months2
    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: 18
    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 No
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 18
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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