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    Summary
    EudraCT Number:2018-004829-82
    Sponsor's Protocol Code Number:GHREDECIDE
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-02-14
    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 ConcernedSweden - MPA
    A.2EudraCT number2018-004829-82
    A.3Full title of the trial
    Effects of the appetite-inducing hormone ghrelin on decision making in healthy volunteers
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of the appetite-inducing hormone ghrelin on decision making in healthy volunteers
    A.4.1Sponsor's protocol code numberGHREDECIDE
    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 SponsorLinköping University
    B.1.3.4CountrySweden
    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 supportSwedish Research Council
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLinköping University
    B.5.2Functional name of contact pointMarkus Heilig
    B.5.3 Address:
    B.5.3.1Street AddressCentre for Social and Affective Neuroscience
    B.5.3.2Town/ cityLinköping
    B.5.3.3Post code58183
    B.5.3.4CountrySweden
    B.5.6E-mailmarkus.heilig@liu.se
    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 nameacyl-ghrelin
    D.3.4Pharmaceutical form Powder for concentrate and solution for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.1CAS number 258279-04-8
    D.3.9.3Other descriptive nameACYL GHRELIN
    D.3.9.4EV Substance CodeSUB167591
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    NA, healthy volunteers
    E.1.1.1Medical condition in easily understood language
    NA, healthy volunteers
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behaviours [F01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Study 1: This is an experimental medicine study to explore potential effects of ghrelin on cognition and motivation. The primary objective of this protocol is to investigate whether ghrelin, administered as an IV infusion to healthy human volunteers, will alter reward processing, delay discounting, risky decision making, and goal-directed learning; and whether it will influence the activity of neural circuitry activated during execution of tasks involving these decision making processes.
    Study 2: This is an exploratory experimental medicine study to examine effects of ghrelin on behaviors of relevance for gambling. The primary objective is to investigate whether ghrelin, administered as an IV infusion to healthy human volunteers, will attenuate loss sensitivity, resulting in continued gambling despite losses in a slot machine task. Secondary objectives are to assess measures of risk aversion using an established Prospect Theory gambling task; and to assess risk taking using the BART.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    see above E.2.1
    E.3Principal inclusion criteria
    1. Age 18-65 years.
    2. Good health as determined by medical history, ECG and clinical assessment of lab tests. Lab tests will include sodium, potassium, creatinine, hemoglobin, EVF, erythrocytes, leukocytes, platelets, MCV, MCH, MCHC, albumin, bilirubin, plasma lipids, ALP, ASAT, ALAT, CRP, GT. The final decision will be according to the judgment of the investigator.
    3. Creatinine ≤ 176 µmol/L.
    4. Females must have a negative urine pregnancy test (hCG) at inclusion and at the start of each study session. Females of childbearing potential who are sexually active and have not been surgically sterilized must agree to use an adequate method of birth control during the study.
    5. Participant must be willing to receive two IV lines.

    Inclusion criteria specific for study 1
    Participant must be willing to undergo an MR scan.

    Inclusion criteria specific for study 2
    Proficiency in Swedish.
    E.4Principal exclusion criteria
    1. Any clinically significant medical condition, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders.
    2. Specific exclusion criteria related to the administration of ghrelin are chronic inflammatory diseases (e.g., Crohn’s disease, ulcerative colitis, celiac disease), diabetes, obesity (BMI ≥ 30 kg/m2), weight ≥ 120 kg, high triglycerides level (> 4,0 mmol/l), history of clinically significant hypotension (e.g., history of fainting and/or syncopal attacks) and/or resting systolic BP < 100 mmHg.
    3. Any use of CNS-active medications.
    4. Unable to provide a negative urine drug screen (including amphetamine, THC, opiates and benzodiazepines).
    5. Pregnancy, intention to become pregnant, or breastfeeding a child.

    Exclusion criteria specific for study 1
    1. Any current clinically significant psychiatric problems including a diagnosis of substance dependence other than nicotine; any history of a past eating disorder, psychotic illness, or bipolar disorder; as determined by medical history, and MINI interview carried out by appropriately trained staff.
    2. Contraindications for MRI scanning, including ferromagnetic objects in the body that are contraindicated for MRI, and claustrophobia.

    Exclusion criteria specific for study 2
    1. Any current clinically significant psychiatric problems including a DSM-5 diagnosis of severe Substance Use Disorder other than nicotine, or Gambling Disorder. Patients will be screened using the Modified MINI Screen [MMS, (43)], the Alcohol Use Disorder Identification Test [AUDIT; (44)], the Drug Use Disorder Identification Test (DUDIT; (45)] and the NORC Diagnostic Screen for Gambling Problems [NODS; (46)]. The results and their clinical significance will be evaluated by a trained healthcare professional (psychiatrically trained nurse or physician). If an indication is obtained that a clinically significant psychiatric disorder may be present, a full structured diagnostic interview [MINI; (47)] will be carried out by appropriately trained staff prior to determining eligibility.
    2. Any lifetime history of problematic gambling.
    E.5 End points
    E.5.1Primary end point(s)
    Study 1:
    The following primary outcome measures will be analyzed
    • Behavioral outcomes on the risky decision making task, the monetary incentive delay task, the probabilistic reversal learning task and the delay discounting task
    • Whole brain fMRI BOLD response during the respective task


    Study 2:
    The following primary outcome measure will be analyzed
    • Number of spins on the slot machine task.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Study 1:

    At two separate sessions while receiving either ghrelin or placebo i.v.-infusions (within subject cross-over)

    Study 2:

    On a single session while receiving either ghrelin or placebo i.v.-infusion (between subject)
    E.5.2Secondary end point(s)
    Study 1:
    The following secondary and exploratory outcome measures will be analyzed
    • Resting state connectivity with seeds in insula, ventral striatum and anterior cingulate
    • Plasma hormone levels

    Study 2:
    The following secondary and exploratory outcomes will be analyzed
    • Overall proportion of choices (out of the total of 18) on the risky decision making task, in which the participant gambles for an uncertain vs a certain outcome.
    • Mean number of pumps on the BART, excluding trial in which the balloon exploded.
    • Percentage choices on the risky decision making task (out of 9) in each of the gain, loss and mixed domains, respectively.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Study 1:

    At two separate sessions while receiving either ghrelin or placebo i.v.-infusions (within subject cross-over)

    Study 2:

    On a single session while receiving either ghrelin or placebo i.v.-infusion (between subject)
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Physiological
    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) 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 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) No
    E.8.2.2Placebo Yes
    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
    Last phone call follow-up of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 74
    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 state74
    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)
    None
    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 Decision2019-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-12
    P. End of Trial
    P.End of Trial StatusOngoing
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