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    Summary
    EudraCT Number:2012-003495-39
    Sponsor's Protocol Code Number:Debio-0932-102
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-09-17
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-003495-39
    A.3Full title of the trial
    A Two-Part, Sequential Design Study to Determine Debio 0932 Absolute Oral Bioavailability, Mass Balance Recovery, Metabolite Profiling and Structural Identification in 3 Cohorts of Healthy Male Subjects
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A two part study to investigate how the
    study drug, Debio 0932, is taken up by the body after taking two different dose levels (Part 1), and recovery of drug (Part 2) in male subjects.
    A.4.1Sponsor's protocol code numberDebio-0932-102
    A.5.4Other Identifiers
    Name:Site Protocol NumberNumber:QBR113845
    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 SponsorDebiopharm SA
    B.1.3.4CountrySwitzerland
    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 supportDebiopharm SA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDebiopharm SA
    B.5.2Functional name of contact pointClinical Trial Management
    B.5.3 Address:
    B.5.3.1Street AddressChemin Messidor 5-7
    B.5.3.2Town/ city1002 Lausanne
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41 21 321 0111
    B.5.5Fax number+41 21 321 0169
    B.5.6E-mailinfo@debiopharm.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 name250 mg Debio 0932 oral immediate release tablet
    D.3.4Pharmaceutical form Tablet
    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.3.9.2Current sponsor codeDEBIO 0932
    D.3.9.4EV Substance CodeSUB31046
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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.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 name100 µg [14C]-Debio 0932 solution for IV administration
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeDEBIO 0932
    D.3.9.4EV Substance CodeSUB31046
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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: 3
    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 name100 mg [14C]-Debio 0932 capsules for oral administration
    D.3.4Pharmaceutical form Capsule
    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.3.9.2Current sponsor codeDEBIO 0932
    D.3.9.4EV Substance CodeSUB31046
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Debio-0932 is currently under development for the treatment of cancer.
    E.1.1.1Medical condition in easily understood language
    Debio-0932 is currently under development for the treatment of cancer.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10048683
    E.1.2Term Advanced cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 of Part 1 of the study is:
    • To determine the absolute oral bioavailability at 2 dose levels of Debio 0932 in healthy male subjects
    The primary objectives of Part 2 of the study are:
    • To assess the mass balance recovery of total radioactivity from excreta in healthy subjects after oral administration of [14C]-Debio 0932
    • To determine the metabolic profile of [14C]-Debio 0932 in plasma, urine and faeces following oral administration
    E.2.2Secondary objectives of the trial
    •To determine the PK of total radioactivity, [14C]-Debio 0932 and [14C] Debio 0932 MET1 following IV) and oral admin of [14C]-Debio 0932 in healthy subjects and the Pk ofDebio 0932/Debio 0932 MET1 following admin of Debio 0932
    •To explore elimination of total radioactivity, [14C]-Debio 0932 and [14C]-Debio 0932-MET1 following IV and oral admin of [14C]-Debio 0932 in healthy subjects
    •To explore the elimination of Debio 0932 and Debio 0932-MET1 in urine following oral administration of Debio 0932 in healthy subjects
    •To provide safety and tolerability information of Debio 0932 in healthy subjects
    •To collect pharmacogenetic data to explore whether they may affect the PK of Debio 0932
    •To determine the chemical structure of “major” metabolites of [14C]-Debio 0932
    •To evaluate the blood to plasma ratio of total radioactivity, [14C]-Debio 0932 and [14C] Debio 0932 MET1
    •To determine the ex vivo protein binding for total radioactivity, [14C]-Debio 0932 and [14C]-Debio 0932-MET1
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Healthy males
    2. Part 1: Age 18 to 65 years of age; Part 2: Age 30 to 65 years of age
    3. Body mass index of 18 to 32 kg/m2 or, if outside the range, considered not clinically significant by the investigator
    4. Must be willing and able to communicate and participate in the whole study
    5. Must provide written informed consent
    6. Must agree to use an adequate method of contraception
    E.4Principal exclusion criteria
    1. Participation in a clinical research study within the previous 3 months
    2. Subjects who are study site employees, or immediate family members of a study site or sponsor employee
    3. Subjects who have previously been enrolled in this study
    4. History of any drug or alcohol abuse in the past 2 years
    5. Regular alcohol consumption >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
    6. Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening
    7. Radiation exposure from clinical studies, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
    8. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
    9. Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
    10. Clinically significant vital signs or ECG values as judged by the investigator
    11. Positive drugs of abuse test result
    12. Positive hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) results
    13. History of clinically significant cardiovascular, renal, hepatic, respiratory or gastrointestinal disease as judged by the investigator
    14. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
    15. Presence or history of allergy requiring treatment. Hayfever is allowed unless it is active
    16. Donation or loss of greater than 400 mL of blood within the previous 3 months
    17. Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 g per day paracetamol) or herbal remedies in the 14 days before IMP administration or within 5 half-lives of the drug, whichever is longer unless not considered to interfere with the objectives of the study as judged by both the PI and sponsor’s medical monitor
    18. Concomitant treatment with any drug on the prohibited medication list (provided separately)
    19. Failure to satisfy the investigator of fitness to participate for any other reason
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for Part 1 is the absolute bioavailability (F) of 250 mg and 500 mg Debio 0932 based on AUC∞.
    The primary endpoints for Part 2 are:
    • Mass balance recovery of total radioactivity in urine, faeces and expired air (Ae, Af, Aa, At, Fe, Ff, Fa and Ft)
    • Radiochromatographic characterisation of the metabolite profile of metabolites of [14C] Debio 0932 in plasma, urine and faeces
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part 1:
    Urine: 0-48 hr post-dose
    Faeces: 0-48 hr post-dose
    Plasma samples (for PK analysis): 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 18, 24, 30, 36, 48, 72, 96 hr post-dose
    Plasma samples (for total radioactivity analysis): 1.75, 1.83, 1.92, 2.0, 2.08, 2.17, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 6, 8, 10, 12, 14, 20, 24, 36, 48, 72, 96 hr post-dose

    Part 2:
    Plasma samples (for PK analysis): 0.25, 0.5, 0.75, 1, 1.5, 1.75, 1.83, 1.92, 2.0, 2.08, 2.17, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 6, 8, 10, 12, 14, 18, 20, 24, 30, 36, 48, 72, 96, 120, 144, 168 hr post-dose
    Urine:0-168 hr post-dose
    Faeces: 0-168 hr post-dose
    Expired Air: 0.5, 1.0, 1.5, 2, 3, 4, 6, 10, 12, 24 hrs post-dose
    E.5.2Secondary end point(s)
    The secondary endpoints for Part 1 of the study are:
    • Determination of the PK profile of total radioactivity, [14C]-Debio 0932 and [14C] Debio 0932-MET1 following an IV microtracer dose of [14C]-Debio 0932 (Tlag, Tmax, Cmax, C24, AUC(0-last), AUC∞, AUC%extrap, λz, T1/2, MRT, Cl, Vd and CLr).
    • Determination of the PK profile of Debio 0932 and Debio 0932-MET1 following oral administration of Debio 0932 (Tlag, Tmax, Cmax, AUC(0-last), AUC∞, AUC%extrap, λz, T1/2, MRT [Debio 0932 only], CL/F, Vz/F and CLr).
    • Recovery of total radioactivity, and if possible, [14C]-Debio 0932 and [14C]-Debio 0932-MET1 in urine, faeces and overall (Ae, Af, At, Fe, Ff and Ft)
    • Recovery of Debio 0932 and Debio 0932-MET1 in urine will be be also compared (Ae and Fe)
    • Collection of further information about the safety and tolerability of Debio 0932 by assessing physical examinations, safety laboratory tests, vital signs, ECGs and AEs.
    • To collect pharmacogenetic data related to cytochromes and other metabolic enzymes/transporters involved in the metabolism and mechanism of action of Debio 0932
    The secondary endpoints of Part 2 of the study are:
    • Determination of the PK profile of total radioactivity, Debio 0932 and Debio 0932 MET1 following oral administration of Debio 0932 (Tlag, Tmax, Cmax, AUC(0-last), AUC∞, AUC%extrap, λz, T1/2 and MRT (total radioactivity and Debio 0932). F will also be determined for total radioactivity and Debio 0932 only using the mean IV data obtained from Part 1).
    • Recovery of [14C]-Debio 0932 and [14C] Debio 0932 MET1 in urine, faeces and overall (Ae, Af, At Fe, Ff and Ft).
    • Determination of a chemical structure of major metabolites of [14C] Debio 0932.
    • Evaluation of the whole blood:plasma concentration ratios of total radioactivity, [14C]-Debio 0932 and [14C]-Debio 0932-MET1.
    • Selected plasma samples will be analysed for protein binding of total radioactivity, [14C]-Debio 0932 and [14C]-Debio 0932-MET1.
    • Collection of further information about the safety and tolerability of Debio 0932 by assessing physical examinations, safety laboratory tests, vital signs, ECGs and AEs.
    • To collect pharmacogenetic data related to cytochomes and other metabolic enzymes/transporters involved in the metabolism and mechanism of action of Debio 0932.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part 1:
    Urine: 0-48 hr post-dose
    Faeces: 0-48 hr post-dose
    Plasma samples (PK): as listed above
    Plasma samples (TR): as listed above
    Pharmacogenetic blood sample: pre-dose

    Part 2:
    Plasma samples (PK): 0.25, 0.5, 0.75, 1, 1.5, 1.75, 1.83, 1.92, 2.0, 2.08, 2.17, 2.25, 2.5, 2.75, 3, 3.5, 4, 5, 6, 8, 10, 12, 14, 18, 20, 24, 30, 36, 48, 72, 96, 120, 144, 168 hr post-dose
    Urine:0-168 hr post-dose
    Faeces: 0-168 hr post-dose
    Expired Air: 0.5, 1.0, 1.5, 2, 3, 4, 6, 10, 12, 24 hrs post-dose
    Pharmacogenetic blood sample: pre-dose
    Whole blood samples:2, 6, 18, 24, 72 hours post-dose
    Plasma (protein binding): 2, 6, 18, 24, 72 hours post-dose
    Plasma (metabolites): 2, 6, 18, 24, 48 hours post-dose
    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 Yes
    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 Information not present in EudraCT
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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
    Last visit by 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 days11
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days11
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state20
    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)
    n/a as this is a study in healthy volunteers
    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 Decision2012-10-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-12-03
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