E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy subjects (hypothyroidism) |
Volontari sani (ipotiroidismo) |
|
E.1.1.1 | Medical condition in easily understood language |
Hypothyroidism |
Ipotiroidismo |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10021114 |
E.1.2 | Term | Hypothyroidism |
E.1.2 | System Organ Class | 10014698 - Endocrine disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the serum levels of T3S after a single oral dose (40/60/80 mcg) in healthy volunteers and relevant absorption pattern. |
Valutare i livelli sierici di T3S dopo somministrazione per via orale di una dose singola (una compressa da 40, 60 o 80 mcg) di T3S. |
|
E.2.2 | Secondary objectives of the trial |
To define the serum profile of TT3 and FT3 after oral administration of T3S and to confirm the safety after T3S oral administration |
Valutare i livelli sierici di TT3 e FT3 (e accessoriamente di FT4 e TSH) dopo somministrazione delle dosi singole di T3S e di confermare la sicurezza di impiego del prodotto. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Provided written Informed Consent and willing to comply with protocol requirements •Age between 18 and 40 years •Either sex Healthy subjects•BMI ranging between 20 and 25 Kg/mq for either gender Subjects coming from the scientific community will be preferable. |
Consenso informato ottenuto e documentato per iscritto; età compresa tra i 18 ed i 40 anni; stato di buona salute (inteso come assenza di processi patologici significativi, rilevabili mediante l’anamnesi, l’esame fisico, i comuni accertamenti bioumorali e l’ECG); body mass index compreso tra 20 e 25. |
|
E.4 | Principal exclusion criteria |
•Presence of any severe metabolic, organ or systemic disease •Presence of any medical condition or other circumstances which would significantly decrease the chance of obtaining reliable data, achieving study objectives or completing the study. •History of allergy, sensitivity or intolerance to the study drugs and/or any of the study drugs formulation ingredients •Assumption of any substance affecting thyroid hormone GI absorption or metabolism (soya and soya derivatives, aluminium/iron or calcium carbonate-containing preparations) •Blood-donation within 30 days before admission to this study •Assumption of an investigational compound within 30 days before admission to this study • History of alcoholism, drug abuse or psychiatric diseases that could invalidate the informed consent or limit the subject compliance with protocol requirements •Pregnancy [Exclude the possibility of pregnancy by testing on site at the institution (serum or urine βHCG; to be retest at Investigator judgement) or by surgical history (e.g., tubal ligation or hysterectomy)]. Menstruated female subject will be strongly recommended to avoid vaginal intercourse starting from signing the Informed Consent until day 5 after dosing. •Breastfeeding •Subjects unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study •Pharmacological treatment ongoing •Skin lesions at the site of the blood sampling •Difficult access to the periferal venous blood vessels •Employees of the investigator or study centre (i.e. principal investigator, co-investigator(s), study coordinators, other study staff, contractors…) with direct involvement in this study or other studies under the direction of the investigator , as well as family members of the employees or the investigator. |
Ogni condizione, medica e non, potenzialmente in grado di ridurre in maniera significativa la possibilità di ottenere dati affidabili, raggiungere gli obiettivi dello studio, di perfezionare il completamento di questo; allergia, ipersensibilità o intolleranza note ai costituenti dei prodotti in studio; assunzione di ogni sostanza potenzialmente in grado di interferire con i processi di assorbimento e metabolismo degli ormoni tiroidei (ad esempio soia e derivati della soia; preparazioni contenente alluminio/calcio carbonato ecc); donazioni di sangue nei trenta giorni antecedenti l’ammissione allo studio; assunzione di ogni medicinale sperimentale nei trenta giorni antecedenti l’ammissione allo studio; storia di alcoolismo, uso non terapeutico di sostanze stupefacenti, patologie neurologiche o psichiatriche che possano inficiare la validità del consenso o compromettere l’aderenza del paziente alle procedure dello studio; gravidanza, allattamento al seno, inadeguate procedure contraccettive (in donne fertili) (un test di gravidanza sarà effettuato nelle donne fertili nel corso delle procedure di screening); pazienti presumibilmente non in grado di comprendere le caratteristiche dello studio e/o di seguirne le procedure; trattamenti farmacologici in atto; presenza di lesioni cutanee nella sede dei prelievi venosi; accesso difficoltoso alla rete venosa superficiale; personale del centro direttamente coinvolto nella gestione dello studio (ad esempio sperimentatore principale, coinvestigatori, personale infermieristico e impiegatizio) e parenti stretti di questo. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The serum levels of T3S |
I livelli sierici di T3S |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Blood sampling at times (hours): -0.5, 1, 2, 4, 8, 12, 24, 48, 72 e 96 |
Prelievi ematici ai tempi (ore): -0.5, 1, 2, 4, 8, 12, 24, 48, 72 e 96 |
|
E.5.2 | Secondary end point(s) |
The serum levels of TT3, FT3, FT4, TSH. |
I livelli sierici di TT3, FT3, FT4, TSH. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
TT3 and FT3 blood sampling at times (hours): -0.5, 1, 2, 4, 8, 12, 24, 48, 72 e 96. FT4 and TSH blood sampling at times (hours):-0.5 and 96 |
TT3 e FT3 prelievi ematici ai tempi (ore): -0.5, 1, 2, 4, 8, 12, 24, 48, 72 e 96. FT4 e TSH prelievi ematici ai tempi (ore): -0.5 e 96 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial 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.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |