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    Summary
    EudraCT Number:2016-004342-28
    Sponsor's Protocol Code Number:PKFT218-1602
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-10-17
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-004342-28
    A.3Full title of the trial
    A comparative, open label, randomized, 2 periods, 2 sequence crossover study to assess the relative bioavailability of sodium oxybate for extended release oral suspension (FT218) formulation (single dose administered at the dose of 6g) versus the marketed reference Xyrem® (at the dose of 2 x 3g ) in healthy volunteers.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare the absorption into the body of the drug sodium oxybate in FT218 in comparison to the currently marketed product Xyrem®.
    A.4.1Sponsor's protocol code numberPKFT218-1602
    A.5.4Other Identifiers
    Name:CRO CodeNumber:APQ672EC-176721
    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 SponsorFlamel Ireland Ltd trading under the business name Avadel Ireland
    B.1.3.4CountryIreland
    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 supportFlamel Ireland Limited trading under the business name Avadel Ireland
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFlamel Ireland Limited trading under the business name Avadel Ireland
    B.5.2Functional name of contact pointClinical Trial Email
    B.5.3 Address:
    B.5.3.1Street AddressBlock 10 Unit 1, Blanchardstown Corporate Park
    B.5.3.2Town/ cityBallycoolin
    B.5.3.3Post codeDublin 15
    B.5.3.4CountryIreland
    B.5.4Telephone number+35314851217
    B.5.5Fax number+35315261077
    B.5.6E-mailclinicaltrials@avadel.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 nameSodium Oxybate for Extended Release Oral Suspension
    D.3.2Product code FT218
    D.3.4Pharmaceutical form Powder for oral suspension
    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 INNSodium Oxybate
    D.3.9.1CAS number 502-85-2
    D.3.9.2Current sponsor codeFT218
    D.3.9.3Other descriptive nameSODIUM OXYBATE
    D.3.9.4EV Substance CodeSUB14731MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 RoleComparator
    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 Xyrem® 500mg/ml Oral Solution
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma B.V.
    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 nameXyrem 500mg/ml oral solution
    D.3.4Pharmaceutical form Oral solution
    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 INNSodium Oxybate
    D.3.9.1CAS number 502-85-2
    D.3.9.3Other descriptive nameSODIUM OXYBATE
    D.3.9.4EV Substance CodeSUB14731MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    A trial on healthy volunteer fore the development of a treatment for cataplexy and excessive daytime sleepiness in narcolepsy.
    E.1.1.1Medical condition in easily understood language
    Cataplexy is an abrupt temporary loss of voluntary muscular function and tone.

    Narcolepsy which is an neurological disorder that affects the control of sleep and wakefulness.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10007738
    E.1.2Term Cataplexy and narcolepsy
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the pharmacokinetics (PK) and relative bioavailability of a single dose of 6 g FT218 formulation taken 2 hours post-evening meal versus 2 doses of 3 g of Xyrem® administered 4 hours apart, first intake 2 hours post-evening meal in healthy volunteers.
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of a single dose of 6 g FT218 formulation taken 2 hours post-evening meal versus 2 doses of 3 g of the reference treatment (Xyrem®) administered 4 hours apart, first intake 2 hours post-evening meal, in healthy volunteers.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The following inclusion criteria must be met for a subject to be eligible for inclusion in the study:

    1. Gender: male or female; females may be of childbearing potential, of non childbearing potential, or postmenopausal

    2. Age: 18-65 years, inclusive, at screening

    3. Body mass index (BMI) : 18.0-28.0 kg/m2

    4. Weight : ≥60 kg

    5. Status: healthy subjects

    6. Race/Ethnicity: “White” (Caucasian)/“Not Hispanic or Latino”

    7. Female subjects must be:
    • postmenopausal for at least 1 year before the screening visit with follicle stimulating hormone (FSH) serum levels consistent with postmenopausal status, as per PI judgment, OR
    • surgically sterile, OR
    • if of childbearing potential, agree to practice at least one highly effective method of contraception from the time of signing informed consent through 90 days after the last dose of study drug or complete abstinence during the study if in line with the preferred and usual lifestyle of the subject.
    Birth control methods considered as highly effective include:

    o Combined (estrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation; oral, intravaginal or transdermal
    o Progesterone-only hormonal contraception associated with inhibition of ovulation; oral, intravaginal or transdermal
    o Hormonal or copper intrauterine device
    o Bilateral tubal occlusion
    o Vasectomized partner

    8. Female subjects of childbearing potential must be non-pregnant and non lactating, and have a negative pregnancy test at screening and each admission to the clinical research center

    9. Male subjects, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from first admission to the clinical research center until 90 days after the follow-up visit. Adequate contraception for the male subject is defined as using hormonal contraceptives or an intrauterine device by his female partner. Also, total abstinence, in accordance with the lifestyle of the subject is acceptable

    10. Normal blood pressure and heart rate (HR) at the screening visit after 5 minutes in supine position:
    • 95 mmHg ≤ systolic blood pressure (SBP) ≤ 140 mmHg
    • 50 mmHg ≤ diastolic blood pressure (DBP) ≤ 90 mmHg
    • 45 beats per minute (bpm) ≤ HR ≤ 90 bpm
    Or considered as not clinically significant as per PI judgment

    11. Normal ECG recording on a 12-lead ECG
    • 120 < PR < 210 ms
    • QRS < 120 ms
    • QTc-interval (Fridericia’s) ≤ 430 ms for male and < 450 ms for female
    • No signs of sick sinus syndrome
    Or considered as not-clinically significant as per PI judgment

    12. Laboratory parameters within the normal range of the laboratory (hematological, blood chemistry tests, urinalysis). Individual values out of the normal range can be accepted if judged as not clinically significant by the PI.

    13. Medical history without major pathology as judged by the PI

    14. All prescribed medication must have been stopped at least 30 days prior to the first admission to the clinical research center. An exception is made for hormonal contraceptives, which may be used throughout the study.

    15. All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John’s Wort) must have been stopped at least 14 days prior to each admission to the clinical research center. An exception is made for paracetamol, which is allowed up to admission to the clinical research center

    16. No known eating disorder such as hyperphagia or food restriction

    17. Willing and able to give written informed consent prior to selection

    18. Willing and able to comply with all study mandated requirements and procedures for the duration of the clinical study

    19. Willing and able to adhere to all study restrictions including:
    • Willingness to comply with the requirement to remain in bed for a minimum of 6 hours after taking the study drug
    • Adherence to concomitant drug washout requirements, as applicable, for the duration of the clinical study
    • Willing to refrain from operating a car or heavy machinery if determined necessary by the PI
    • Willing to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks), and grapefruit (juice) from 48 hours prior to each admission to the clinical research center and during the stays in the clinical research center
    • Willing to abstain from intensive muscular effort from 96 hours prior to each admission to the clinical research center and during the stays in the clinical research center
    • Willing to abstain from smoking or consuming nicotine during the stays in the clinical research center

    20. Covered by Health Insurance System
    E.4Principal exclusion criteria
    A subject who meets any of the following exclusion criteria will not be eligible for inclusion in the study:

    1. Employee of PRA or the Sponsor

    2. The presence of any unstable or clinically significant medical or psychiatric disorders (as determined by medical or psychiatric history, physical examination, and/or clinical laboratory test) which in the opinion of the PI may either put the subject at risk by participation in the study, or may influence the results of the study

    3. History of seizure, head trauma, or past-intracranial surgery

    4. Any finding in the medical history, physical examination or clinical laboratory tests giving reasonable suspicion of a disease that would contraindicate taking FT218, or a known poor tolerability to the active compound

    5. Subjects with a previous history or current ideation of suicide attempt

    6. Subjects with a medical diagnosis of Major Depression, as defined by the DSM-IV Criteria for Major Depression Disorder, which in the opinion of the PI would impact subject safety and place the subject at risk by participation in the study

    7. Subjects with an O2 saturation of less than 95% at screening or first admission, as measured by pulse oximetry (on room air while fully awake), or subjects with known or suspected respiratory difficulty or any condition that may compromise a subject’s breathing or ability to maintain adequate O2 saturation.

    8. Subjects diagnosed with sleep apnea or at high risk for sleep apnea, reporting a history of loud snoring (louder than talking or loud enough to be heard through closed doors), or observed to stop breathing during sleep.

    9. Subjects who have a history of drug or alcohol use that, in the opinion of the PI would interfere with study subject safety and adherence to study requirements

    10. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants and alcohol)

    11. Occurrence of heartburn, or any surgical intervention (e.g., cholecystectomy) which would be expected to influence the absorption of drugs

    12. Frequent headaches and/or migraine, recurrent nausea and/or vomiting

    13. Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease in SBP or DBP ≥ 20 mmHg within 2 minutes when changing from the supine to the standing position

    14. Donation or loss of more than 100 mL of blood within 60 days prior to the first drug administration. Donation or loss of more than 1.5 liters of blood (for men) / more than 1.0 liters of blood (for women) in the 10 months prior to the first drug administration in the current study

    15. General anesthesia scheduled during the study

    16. Known contraindication/allergy/sensitivity/intolerance to the study drug, sodium oxybate, or the inactive ingredients of FT218

    17. Subject who cannot be contacted in case of emergency

    18. Excessive consumption of beverages with xanthine bases (> 8 cups or glasses/day)

    19. Received any known hepatic or renal clearance altering agents for a period of 30 days prior to first drug administration

    20. Known hepatitis B surface antigen (HBsAg)-positive status or known or suspected active hepatitis C virus (HCV) infection

    21. Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome related illness

    22. Subject who, in the judgment of the PI, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development

    23. Subject in the exclusion period of a previous study as registered in the applicable databases

    24. Subject under administrative or legal supervision

    25. Known succinic semialdehyde dehydrogenase deficiency

    26. Participation in a drug study within 60 days prior to the first drug administration in the current study. Participation in more than 3 other drug studies (for men) / more than 2 other drug studies (for women) in the 10 months prior to the first drug administration in the current study

    27. Significant and/or acute illness within 5 days prior to the first drug administration that may impact safety assessments, in the opinion of the PI

    Please note that subjects should refrain from consumption of any foods containing poppy seeds within 48 hours (2 days) prior to screening and each admission to the clinical research center to avoid false positive drug screen results. In addition, they should refrain from strenuous exercise within 96 hours (4 days) prior to screening and each admission as this could result in abnormal clinical laboratory values.
    E.5 End points
    E.5.1Primary end point(s)
    Plasma PK parameters estimated using non-compartmental analysis (NCA), as appropriate: tlag,Cmax, C8h, tmax, λz, t½, AUClast, AUC0-inf, AUC0 8h, AUC%extra, Frel
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1 on Period 1
    Day 1 on Period 2
    E.5.2Secondary end point(s)
    Clinical and laboratory safety: safety will be evaluated based on reported adverse events, physical examination, vital signs, ECG and safety laboratory test results.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the duration of the study.
    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 No
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    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) Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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.8.5The trial involves multiple Member States No
    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 No
    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
    Defined as the date of the last visit of the last subject.
    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 months1
    E.8.9.1In the Member State concerned days
    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: 24
    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.4.1In the member state24
    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)
    Following end of the subject’s participation in the clinical study no further study drug will be dispensed.
    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 Decision2017-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-01-05
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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