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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   41232   clinical trials with a EudraCT protocol, of which   6757   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).

    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2010-023494-19
    Sponsor's Protocol Code Number:KPT3-07/2010
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-12-27
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2010-023494-19
    A.3Full title of the trial
    A Phase IIa, Multi-Centre, Double-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of K(D)PT after Multiple Ascending Doses in Patients with Active Mild to Moderate Ulcerative Colitis
    A.4.1Sponsor's protocol code numberKPT3-07/2010
    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 SponsorDr. August Wolff GmbH & Co. KG Arzneimittel
    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.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 nameLysine-D-Proline-Threonine
    D.3.2Product code K(D)PT
    D.3.4Pharmaceutical form Powder for oral solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 liquid
    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
    Ulcerative colitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the trial is to assess the safety and tolerability of K(D)PT after administration of multiple ascending doses in patients with active mild to moderate ulcerative colitis.
    E.2.2Secondary objectives of the trial
    To determine the pharmacokinetics (PK) of K(D)PT after administration of multiple ascending doses in patients with active mild to moderate ulcerative colitis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of signed, dated and written informed consent prior to any study specific procedures.
    2. Adult males/females aged 18 to 70 years inclusive.
    3. Have a body mass index (BMI) ≥18 and ≤35 kg/m2.
    4. Females must have a negative pregnancy test at screening and on admission to the unit.
    5. Females of child-bearing potential must agree to use medically acceptable methods of contraception.
    6. Females of non-child-bearing potential should fulfil either of the following criteria at screening:
    - post menopausal defined as amenorrhoea for greater than 1 year following cessation of all exogenous hormonal treatments and with follicle stimulating hormone (FSH) and luteinising hormone (LH) in the laboratory defined post-menopausal range
    - documentation of irreversible surgical sterilisation by bilateral oophorectomy, bilateral salpingectomy and hysterectomy but not tubal ligation.
    7. Male patients must avoid fathering.
    8. Mild to moderate active ulcerative colitis confirmed by a CAI between 4 and 9.
    9. No pre-treatment of active ulcerative colitis except for:
    - stable dose of mesalazine, sulfasalazine or olsalazine in the usual maintenance dose for >4 weeks before time of consent (the medication may be optimised [and administered via the oral or rectal route] by a referring gastroenterologist just before the patient enters the study, i.e within 5 days of first dose of IMP but not after first dose)
    - stable dose of azathioprine or mercaptopurine in the usual maintenance dose for >4 weeks before time of consent (the medication may be optimised [and administered via the oral or rectal route] by a referring gastroenterologist just before the patient enters the study, i.e within 5 days of first dose of IMP but not after first dose).
    E.4Principal exclusion criteria
    1. Previous participation in any clinical study with K(D)PT.
    2. Morbus Crohn.
    3. Any clinically relevant abnormal findings in physical examination or clinical laboratory tests (clinical chemistry, haematology, urinalysis, coagulation) at screening, vital signs (supine blood pressure and heart rate) or ECG pre-dose Day 1, which, in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study.
    4. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study or influence the results or the patient’s ability to participate in the study.
    5. History of bleeding disturbance or thrombotic disorder.
    6. History of or current alcohol or drug abuse, as judged by the Investigator.
    7. Participation in another investigational drug study within 3 months before first administration of IMP or participation in a method development study (no drug) 1 month prior to first administration of IMP (Note: participation is identified as the completion of a treatment-related visit).
    8. Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks prior to the first administration of IMP.
    9. Donation of blood within 3 months, or donation of plasma within 14 days, prior to first administration of IMP.
    10. Other pre-treatment of ulcerative colitis than mesalazine, sulfasalazine, olsalazine, azathioprine or mercaptopurine.
    11. Proctosigmoiditis (less than 25 cm).
    12. Use of antibiotics within 6 weeks prior to first administration of IMP.
    13. Previous anti-TNF therapy.
    14. Marcumarisation or moderate to severe grade coagulation defects as judged by the Investigator.
    15. Haemoglobin (Hb) value below 100 g/L (females) or 110 g/L (males).
    16. QTcF >450 ms or <350 ms or QT >500 ms or other ECG abnormality making interpretation more difficult as judged by the Investigator.
    17. A definite or suspected personal history of intolerance or hypersensitivity to drugs and/or their excipients, judged to be clinically relevant by the Investigator.
    18. Significant hypersensitivity or allergy, as judged by the Investigator.
    19. Allergy against methylparaben or propylparaben.
    20. Positive results on screening tests for hepatitis B and/or C and/or human immunodeficiency virus (HIV).
    21. Positive result on screening tests for drugs of abuse at screening.
    22. Positive screen for alcohol breath test at screening/admission to the unit.
    23. Positive stool result for any of the enteric pathogens: Clostridium, Salmonella, Shigella, Campilobacter or Yersinia.
    24. Involvement in the planning and conduct of the study.
    25. Planned in-patient surgery, dental procedure or hospitalisation during the study.
    26. Patients who in the opinion of the Investigator should not participate in the study.
    27. Patients who are unwilling or unable to participate in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Safety evaluation include vital signs, ECG parameters, physical examination, safety laboratory tests and adverse events.

    If data allows, the following PK parameters will be determined for K(D)PT and its metabolite DKP on Day 1:
    Cmax, tmax, AUC(0-24), MR

    If data allows, the above PK parameters will be determined for K(D)PT and its metabolite DKP also on Day 6. In addition, the following PK parameters will be determined Day 6:
    tlast, AUC(0-t), t½, CL/F, Vz/F, Rac, MRT, Ae, CLR

    Steady-state will be evaluated by graphical presentation of pre-dose plasma concentrations (Ctrough) Days 2 (i.e. the Day 1 24 hour sample), 6 and 7 (i.e. the Day 6 24 hour sample) versus time (day) plots.

    The following PK diagnostic parameters from Day 6 will be calculated and listed but not summarised by descriptive statistics in tables:
    • The time interval of the log-linear regression to determine t½ (lambda lower/upper)
    • Number of data points included in the log-linear regression analysis (a minimum of 3 points will be used).
    • Regression coefficient (Rsq), if Rsq is less than 0.80, then t½, Vz/F and MRT will be flagged for low precision.
    Additional PK parameters may be determined if considered relevant.

    Safety Review Committee and Data Safety Monitoring Board will evaluate available safety, tolerability and PK data between each cohort.

    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 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. 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 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 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 concerned3
    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 Yes
    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
    End of study is defined as last patient last visit (LPLV), which is the timepoint after which no patient will be exposured to study related activities (follow-up).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    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 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.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 12
    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 Decision2011-02-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-08-07
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