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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2007-005241-38
    Sponsor's Protocol Code Number:LX6171.1-201-AAMI
    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:2007-10-17
    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
    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 number2007-005241-38
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Study to Determine Safety and Tolerability of LX6171 Oral Suspension Dosed for 28 Days in Subjects Exhibiting Age Associated Memory Impairment (AAMI) with a Lead-in, Open-Label, Single-Dose Relative Bioavailability Study of LX6171 Oral Suspension in Healthy Elderly Subjects
    A.4.1Sponsor's protocol code numberLX6171.1-201-AAMI
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLexicon Pharmaceuticals Incorporated
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameLX6171 40 mg/ml
    D.3.2Product code LX6171 40 mg/ml
    D.3.4Pharmaceutical form Oral suspension
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeLX6171
    D.3.9.3Other descriptive nameLP-512064, ((3'-chlorobiphenyl-4-yl) (1-(pyrimidin-2-yl) piperidin-4-yl) methanone
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 nameLX6171 80 mg/ml
    D.3.2Product code LX6171 80 mg/ml
    D.3.4Pharmaceutical form Oral suspension
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeLX6171
    D.3.9.3Other descriptive nameLP-512064, ((3'-chlorobiphenyl-4-yl) (1-(pyrimidin-2-yl) piperidin-4-yl) methanone
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboOral suspension
    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
    Age-Associated Memory Impairment (AAMI)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10027175
    E.1.2Term Memory impairment
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    In stage A, the primary objective is:
    - To compare the relative bioavailability of a single dose of 300 mg LX6171 using a 40mg/mL and an 80mg/mL formulated suspension;
    - To evaluate plasma concentrations of LX6171 and its major metabolite LP-523122 after a single 300 mg administration of LX6171 oral suspension at two concentrations (40 mg/mL and 80 mg/mL), in order to determine doses to be utilized over a 28 day period (see stage B).

    In stage B, the primary objective is:
    - To evaluate the safety and tolerability of 2 dose levels LX6171 oral suspension when administered for 28 days, in subjects exhibiting AAMI
    E.2.2Secondary objectives of the trial
    In stage A, the secondary objective is:
    - To evaluate the safety and tolerability of single doses of 300 mg of LX6171 utilizing two different concentrations of oral suspension (40 mg/mL and 80 mg/mL) in healthy elderly subjects

    In stage B, the secondary objective is:
    - To evaluate effects of multiple doses of LX6171 oral suspension on cognition in subjects exhibiting AAMI;
    - To evaluate plasma concentrations of LX6171 and its major metabolite LP-523122 after administration of LX6171 oral suspension for 28 days, in subjects exhibiting AAMI
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Stage A of the study:
    - Males or females 60-80 years old;
    - Females must be post-menopausal (defined as two years without menses) or surgically sterile (defined by surgical sterilization, hysterectomy or bilateral salpingo-oophorectomy);
    - Vital signs (after at least 3 minutes resting in a supine position) which are within the following ranges or considered not clinically significant if outside these ranges:
    - Systolic blood pressure, 100-140 mmHg
    - Diastolic blood pressure, 60-100 mmHg
    - Heart rate, 60-100 bpm
    - Non-smokers or very light smokers (less than or equal to 10 cigarettes per day) who are able to abstain from smoking during the residential part of the study;
    - Body weight between 50 and 100 kg and body mass index (BMI) between 18 and 30 kg/m2 or, if outside the range, not clinically significant and agreed with Sponsor and Investigator;
    - Negative urine screen for drugs of abuse at screening and on the day of admission (Day 1);
    - Negative hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), and HIV 1 and HIV 2 antibody test results must be obtained within the last 21 days prior to study admission;
    - Ability to provide written, informed consent.


    Stage B of the study:
    - Adult males and females 60-80 years (inclusive) old;
    - Females must be post-menopausal (defined as two years without menses) or surgically sterile (defined by surgical sterilization, hysterectomy or bilateral salpingo-oophorectomy);
    - Complaints of memory loss in everyday life as reflected by a score of 25 or more on the Memory Complaint Questionnaire (MAC-Q);
    - Memory test performance of one standard deviation below the mean established for young adults on the Logical Memory I Subtest of the Wechsler Memory Scale-Revised (WMS-R) , but not more than a standard deviation below the age-adjusted mean on the test (score of 11 to 19, inclusive);
    - Vital signs (after at least 3 minutes resting in a supine position) which are within the following ranges or considered not clinically significant if outside these ranges:
    o Systolic blood pressure, 100-140 mmHg
    o Diastolic blood pressure, 60-100 mmHg
    o Heart rate, 60-100 bpm
    - Body weight between 50 and 100 kg and BMI between 18 and 30 kg/m2 or, if outside the range, not clinically significant and agreed with Sponsor and Investigator;
    - Negative urine screen for drugs of abuse at screening;
    - Negative hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), and HIV 1 and HIV 2 antibody test results must be obtained within the last 28 days prior to study admission;
    - Non-smokers or very light smokers (less than or equal to 10 cigarettes per day) who are able to abstain from smoking during the residential part of the study
    - Ability to provide written, informed consent;
    E.4Principal exclusion criteria
    Stage A of the study:
    - A need for or having taken any medication within 21 days of dosing, with the exception of hormone replacement therapy, ibuprofen and paracetamol;
    - Administration of any investigational agent within 12 weeks of study entry;
    - Existence of any surgical or medical condition that, in the judgment of the Investigator, might interfere with the absorption, distribution, metabolism, or excretion of LX6171;
    - Clinically significant abnormal physical findings;
    - Clinically significant laboratory abnormality;
    - Clinically significant abnormalities on resting Electrocardiogram (ECG);
    - Donation or loss of greater than 400 mL of blood within 12 weeks of study entry;
    - Serious adverse reaction or hypersensitivity to any drug;
    - Known history of hepatic disease or significantly abnormal liver function tests (greater than 1.5 times the upper limit of normal) on study entry;
    - History of alcoholism or substance abuse within three years prior to study entry;
    - Known history of significant hematological abnormalities;
    - Concurrent conditions that could interfere with the safety and/or tolerability measurements;
    - Inability to communicate or cooperate with the study staff for any reason

    Stage B of the study:
    - Any neurological disorder that could produce cognitive deterioration as determined by history, clinical neurological examination, and, if indicated neuroradiologic examinations. Such disorders include Alzheimer’s Disease, Mild Cognitive Impairment, Parkinson's disease, stroke, intracranial hemorrhage, local brain lesions including tumors, and normal pressure hydrocephalus;
    - History of any infective or inflammatory brain disease, including those of viral, fungal, or syphilitic etiologies;
    - Evidence of dementia as determined by a score of 26 or less on a Mini-Mental State Examination (MMSE);
    - Evidence of depression as determined by a score of 11 or higher on the Geriatric Depression Scale (GDS);
    - Evidence of delirium, confusion, or other disturbances of consciousness;
    - Clinically significant cardiovascular, hepatic, renal, endocrine, neurological, or psychiatric disorders that could be responsible for memory loss in the judgment of the investigator;
    - Current psychiatric diagnosis according to DSM-IV criteria of depression, mania, or any major psychiatric disorder;
    - Evidence of significant cerebral vascular pathology as determined by a Hachinski Ischemic Score of 4 or more, or by neuroradiologic examination;
    - History of repeated minor head injury (e.g. in boxing) or a single injury resulting in a period of unconsciousness for 20 minutes or more;
    - Baseline laboratory values indicative of clinically significant co morbidity;
    - History of myocardial infarction within the past 12 months or evidence of recent infarction on ECG;
    - Current diagnosis or history of alcoholism or drug dependence, and not able/willing to commit to alcohol restrictions;
    - A need for having taken any medication within 21 days of dosing, with the exception ofhormone replacement therapy, ibuprofen, paracetamol, daily vitamins and aspirin;
    - Use of dietary supplements containing Huperzine A, gingko biloba, phosfatidylserine or docosahexanoic acid (DHA) within 15 days of baseline evaluation or reasonably expected to use these supplements during the course of the study are not eligible to participate.
    - Administration of any investigational agent within 12 weeks of study entry;
    - Donation or loss of greater than 400 mL of blood within 12 weeks of study entry;
    - Concurrent conditions that could interfere with the safety and/or tolerability measurements;
    - Inability to communicate or co-operate with the study staff for any reason.
    E.5 End points
    E.5.1Primary end point(s)
    Stage A and B:
    - pharmacokinetic characteristics
    - safety and tolerability

    Stage B: Weekly cognition will be assessed using the following instruments:
    - A standardized, validated cognitive assessment battery from Cognitive Drug Research (CDR)
    - Memory Assessment Clinics Self-Rating Scale (MAC-S)
    - Rey Auditory Verbal Learning Test (RAVLT)
    - One-Week Delayed Recall Test (OWDRT)
    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 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 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 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 No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Stage A: open label, Stage B: Double Blind
    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.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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 Information not present in EudraCT
    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
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    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 Decision2007-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-09-24
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