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    Summary
    EudraCT Number:2013-001766-42
    Sponsor's Protocol Code Number:D1/09/13
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-01-05
    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 ConcernedUK - MHRA
    A.2EudraCT number2013-001766-42
    A.3Full title of the trial
    A Multiple-Dose, Single Period, Phase II Dose Ranging Study to Examine Testagen™ TDS®-Testosterone 5% in Adult Male Subjects
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Topical Testosterone Replacement in Patient Volunteers with low blood testosterone levels.
    A.3.2Name or abbreviated title of the trial where available
    Testagen™ Dose Ranging D1-09-13
    A.4.1Sponsor's protocol code numberD1/09/13
    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 SponsorSeahorse Scientific Services Ltd.
    B.1.3.4CountryUnited Kingdom
    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 supportLangford Research Institute
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportThermofisher Scientific
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportAdvanced Therapies Centre @ The London Clinic
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSeahorse Scientific Services Ltd.
    B.5.2Functional name of contact pointProf Art Tucker
    B.5.3 Address:
    B.5.3.1Street Address'Nonsuch' House, 21, Rhodesia Road,
    B.5.3.2Town/ cityLeytonstone,
    B.5.3.3Post codeE11 4DF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number07887852994
    B.5.5Fax number02082578417
    B.5.6E-maila.t.tucker@seahorsescientific.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 nameTestagen™ TDS®-Testosterone 5%
    D.3.4Pharmaceutical form Concentrate for cutaneous spray, emulsion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    Transdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTestosterone
    D.3.9.1CAS number 65-06-5
    D.3.9.2Current sponsor codeG03BA03
    D.3.9.3Other descriptive namedelta1-dihydrotestosterone, 17β-hydroxy-5alpha-androst-1-en-3-one, 1-Testo, 1-T
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50mg/ml
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Male Hypogondism
    E.1.1.1Medical condition in easily understood language
    Low male testosterone levels
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10055043
    E.1.2Term Blood dihydrotestosterone decreased
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10005812
    E.1.2Term Blood testosterone abnormal
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10005811
    E.1.2Term Blood testosterone
    E.1.2System Organ Class 10022891 - Investigations
    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 objective is to determine the pharmacokinetic outcome profile of several doses of a topically applied formulation of Testagen™ TDS®-Testosterone administered daily by pump dispenser spray to hypogonadotropic/low testosterone adult male subjects over a week's (7 days) time.
    E.2.2Secondary objectives of the trial
    The secondary objective is to evaluate the tolerability and local and systemic effects of Testagen™ TDS®-Testosterone.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects meeting all of the following criteria will be eligible from entry into the study:

    1. Hypogonadal Male subjects – morning testosterone level ≤300 ng/dL (10.4 nmol/L).
    NOTE: Mean of 2 samples collected on Visit 2 and Visit 3 following HRT washout.
    2. 18 and 75 years of age, inclusive.
    3. The subject is willing and able to read, understand the Subject Information Sheet and provide written informed consent.
    4. The subject has a body mass index (BMI) within 18-30 kg/m2.
    5. The subject is in otherwise good health as determined by medical history and physical examination.
    6. The subject is a non-smoker.
    7. The subject must agree to comply with the placement of an indwelling catheter on two separate occasions and the drawing of multiple blood samples over a 24-hour period for the pharmacokinetic assessments.
    8. Subject agrees to use appropriate contraception methods during the study.
    9. The subject is willing and able to comply with all testing and requirements defined in the protocol.
    10. The subject is willing and able to return to the study site for all visits
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria will be excluded from entry into the study:

    1. The subject has any relevant deviations from normal in physical examination, electrocardiogram (ECG), or clinical laboratory tests (ALT or AST greater than 2 times the upper limit of normal, or renal dysfunction (creatinine >2mg/dL),
    2. The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease.
    3. The subject has had a clinically significant illness within 30 days preceding entry into this study.
    4.The subject has a known allergy or history of hypersensitivity to Testosterone or similar compounds.
    5. The subject has used any prescription medication within 14 days or over-the-counter (OTC) medication or alcohol within 48 hours of dosing or intends to use any prescription or OTC medication during the study that may interfere with the evaluation of study medication.
    6. The subject has donated or lost a significant volume of blood (>450mL) within four (4) weeks of the study, and their haemoglobin concentration and haematocrit have not returned to within 5% of normal.
    7. The subject has a Haematocrit level >51% or significant anaemia Haematocrit <35%)
    8. The subject has a history of substance abuse or a current positive urine drug screen or urine alcohol test.
    9. Alcohol consumption greater than community norms (i.e. more than 21 standard drinks per week for males, or more than 14 standard drinks per week for females).
    10. Subjects who have received an investigational drug or have used an investigational device in the 30 days prior to study entry.
    11. Subjects with an American Urological Association Symptom Index for Benign prostatic hyperplasia score greater than 7 and/or elevated PSA reading >4.0 ng/ml/
    12. Subjects with a history of prostate or breast carcinoma
    13. Subject with a partner with a history of breast cancer.
    14. Subjects with prostatic mass on screening physical examination.
    15. Active deep vein thrombosis, thromboembolic disorders or history of these conditions
    16. Subjects with a history of significant skin disease.
    17. Subjects with a history of sleep apnoea.
    18. Subject with a partner of child bearing potential who is not willing to use adequate contraception ((hormonal or barrier method of birth control; abstinence) for the duration of the trial.
    NOTE: Subjects are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
    19. Subject whose partner is pregnant or breastfeeding.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this study is to determine the pharmacokinetic profile of a topically applied formulation of Testagen™ TDS®−Testosterone administered by pump dispenser spray to hypogonadotropic/low testsoterone adult male Patient Volunteers.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Pharmacokinetic parameters will be summarised by number of observations (N), mean, standard deviation (SD), coefficient of variance (CV), median, maximum and minimum values. In addition, geometric means (GM) and geometric CVs will be calculated for AUC0-24 and Cmax. Summary statistics for Tmax, Lambda_Z and T½ will include N, mean, SD, median, minimum and maximum values.
    E.5.2Secondary end point(s)
    The aim of testosterone replacement therapy is to produce serum levels that mimic the normal testosterone production and metabolism. The primary therapeutic purpose of Testagen™ TDS®-Testosterone is the restoration of serum testosterone levels to within the age-adjusted normal range for the Subject utilizing a safe transdermal delivery vehicle.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Full study duration.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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
    LVLS
    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 months4
    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 months4
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 13
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 48
    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)
    The TDS system will not be avaiable for continued therapeutic usage following completion of the planned study. All patients will return to clinical management following completion of the study. Further they will be informed of the planned phase III study which is currently in planning and regulatory approval.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Not Applicable
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-03-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-15
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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