Healthy subjects (hypothyroidism) MedDRA version: 14.0 Level: PT Classification code 10021114 Term: Hypothyroidism System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Product Name: T3 sulfate
Pharmaceutical Form: Tablet
Current Sponsor code: B25350/1
Other descriptive name: T3- sulfate monosodium salt
Concentration unit: µg microgram(s)
Concentration type: equal
Co
Sponsors
BRACCO
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 ßHCG; 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the serum levels of T3S after a single oral dose (40/60/80 mcg) in healthy volunteers and relevant absorption pattern.;Secondary Objective: To define the serum profile of TT3 and FT3 after oral administration of T3S and to confirm the safety after T3S oral administration;Primary end point(s): The serum levels of T3S;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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The serum levels of TT3, FT3, FT4, TSH.;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 | — |
Countries
Italy
Contacts
Public ContactDirezione Medica
Bracco
Outcome results
None listed