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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7311   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2017-003956-22
    Sponsor's Protocol Code Number:GS-US-337-2091
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-09-29
    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 number2017-003956-22
    A.3Full title of the trial
    A Phase 1 Relative Bioavailability and Food Effect Study of a Pediatric Oral Granule Formulation of Ledipasvir/Sofosbuvir in Healthy Adult Subjects
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study in healthy adults to compare the bioavailability of Harvoni tablets to that of pediatric granules.
    A.4.1Sponsor's protocol code numberGS-US-337-2091
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/063/2017
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGilead Sciences, 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 supportGilead Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences, Inc.
    B.5.2Functional name of contact pointBenedetta Massetto
    B.5.3 Address:
    B.5.3.1Street Address333 Lakeside Drive
    B.5.3.2Town/ cityFoster City
    B.5.3.3Post codeCA, 94404
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1650522-5057
    B.5.6E-mailBenedetta.Massetto@gilead.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 Yes
    D.2.1.1.1Trade name Harvoni 90 mg/400 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameHarvoni
    D.3.4Pharmaceutical form Film-coated 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 INNLedipasvir
    D.3.9.1CAS number 1256388-51-8
    D.3.9.3Other descriptive nameLEDIPASVIR
    D.3.9.4EV Substance CodeSUB120165
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSofosbuvir
    D.3.9.1CAS number 1190307-88-0
    D.3.9.3Other descriptive nameSOFOSBUVIR
    D.3.9.4EV Substance CodeSUB121170
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 nameLDV/SOF capsules
    D.3.4Pharmaceutical form Granules
    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 INNLedipasvir
    D.3.9.1CAS number 1256388-51-8
    D.3.9.3Other descriptive nameLEDIPASVIR
    D.3.9.4EV Substance CodeSUB120165
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSofosbuvir
    D.3.9.1CAS number 1190307-88-0
    D.3.9.3Other descriptive nameSOFOSBUVIR
    D.3.9.4EV Substance CodeSUB121170
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 infection
    E.1.1.1Medical condition in easily understood language
    Hepatitis C
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10019744
    E.1.2Term Hepatitis C
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    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
    The primary objectives of this study are as follows:
     To evaluate the relative bioavailability of a pediatric granules formulation of LDV/SOF relative to tablet formulation in healthy subjects.
     To evaluate the effect of concomitant food intake on the pharmacokinetics of a pediatric granules formulation LDV/SOF.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is as follows:
     To evaluate the safety and tolerability of a pediatric granules formulation of LDV/SOF following single-dose administration in healthy subjects.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
    1. Have the ability to understand and sign a written informed consent form (ICF),
    2. Be between 18 and 45 years of age, inclusive
    3. Must have a calculated BMI between ≥19.0 to ≤30.0 kg/m2 at Screening
    4. Creatinine clearance (CLCr) must be ≥90 mL/min
    5. Females of childbearing potential (as defined in Appendix 3) must have a negative serum pregnancy test at Screening and Day -1
    6. Females of childbearing potential must agree to utilize protocol recommended highly effective contraception methods (as defined in Appendix 3) from 3 weeks prior to clinic admission until 30 days following the last dose of study drug
    7. Male subjects must agree to utilize a highly effective method of contraception (as defined in Appendix 3) during heterosexual intercourse from clinic admission until 90 days following the last dose of study drug.
    8. Male subjects must agree to refrain from sperm donation from Day -1 until at least 90 days after the study drug dose
    9. Subjects must have refrained from blood donation within 56 days or plasma donation within 7 days of study dosing and from clinic admission until 30 days following the last dose of study drug
    10. In the opinion of the investigator, subjects must be in good health based upon medical history and physical examination (including vital signs)
    11. Screening laboratory evaluations without clinically significant abnormalities as assessed by the investigator
    12. Be willing and able to comply with all study requirements
    E.4Principal exclusion criteria
    Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
    1. Alcohol or substance abuse as assessed by the investigator
    2. A positive screening test result for human immunodeficiency virus type 1 (HIV-1) antibody, Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) antibody
    3. Nursing female
    4. Have previously been participated in an investigational trial involving administration of any investigational compound (last dose) within 30 days prior to the study dosing (Day 1)
    5. Have poor venous access limiting phlebotomy
    6. Have been vaccinated within 90 days, or for the influenza vaccine, within 14 days prior to study dosing
    7. Have taken any prescription medications or over-the-counter medications including herbal products within 28 days of commencing study drug dosing with the exception of vitamins and/or acetaminophen and/or ibuprofen and/or hormonal contraceptive medications
    8. Have taken systemic steroids, immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening or expected to receive these agents during the study
    9. Have a history of any of the following:
    a. Significant drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity)
    b. Significant serious skin disease, such as but not limited to, rash or eruptions, food allergy, eczema, psoriasis, or urticaria
    c. Known hypersensitivity to the study drugs, the metabolites or to formulation excipients (see Section 5.2.1)
    d. Syncope, palpitations, or unexplained dizziness
    e. Liver disease or liver function tests such as alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT), aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT), serum total bilirubin, or alkaline phosphatase above the upper limit of normal at Screening
    f. Severe peptic ulcer disease, gastroesophageal reflux disease, or other gastric acid hypersecretory conditions requiring prolonged (> 6 months) medical treatment
    g. Medical or surgical treatment that permanently alters gastric absorption (eg, gastric or intestinal surgery)
    h. Significant cardiac disease (including history of myocardial infarction based on electrocardiogram [ECG] and/or clinical history, any history of ventricular tachycardia, congestive heart failure, or dilated cardiomyopathy with left ventricular ejection fraction < 40%) or a family history of Long QT Syndrome
    10. The following ECG abnormalities at Screening: QRS > 120 msec; heart rate < 45 beats per minute; second or third degree heart block, QTcF interval > 450 msec for males or > 470 msec for females; PR interval > 200 msec and any other clinically relevant abnormality
    11. Believed, by the study investigator, to be inappropriate for study participation for any reasond. Syncope, palpitations, or unexplained dizziness
    e. Liver disease or liver function tests such as alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT), aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT), serum total bilirubin, or alkaline phosphatase above the upper limit of normal at Screening
    f. Severe peptic ulcer disease, gastroesophageal reflux disease, or other gastric acid hypersecretory conditions requiring prolonged (> 6 months) medical treatment
    g. Medical or surgical treatment that permanently alters gastric absorption (eg, gastric or intestinal surgery)
    h. Significant cardiac disease (including history of myocardial infarction based on electrocardiogram [ECG] and/or clinical history, any history of ventricular tachycardia, congestive heart failure, or dilated cardiomyopathy with left ventricular ejection fraction < 40%) or a family history of Long QT Syndrome
    10. The following ECG abnormalities at Screening: QRS > 120 msec; heart rate < 45 beats per minute; second or third degree heart block, QTcF interval > 450 msec for males or > 470 msec for females; PR interval > 200 msec and any other clinically relevant abnormality
    11. Believed, by the study investigator, to be inappropriate for study participation for any reason
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints are PK parameters Cmax, AUClast, and AUCinf, for SOF, GS-566500, GS-331007, and LDV.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Scheduled assessment points throughout the treatment period
    E.5.2Secondary end point(s)
    The secondary endpoints are the incidences of AEs, laboratory abnormalities and vital signs.
    The secondary PK endpoints are % AUCexp, Tmax, Clast, Tlast, λz, CL/F, and t1/2 as appropriate.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Scheduled assessment points throughout the treatment period
    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 Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study Yes
    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 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 Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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
    LPLV
    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 months0
    E.8.9.2In all countries concerned by the trial days31
    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: 42
    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 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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 42
    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
    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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