Two-groups, open label, fixed-sequence study to evaluate the effect of CYP3A4/P-gp inhibition (Itraconazole) or CYP1A2/3A4 inhibition (Fluvoxamine) on the single-dose PK of MEN1611 in healthy subjects. - A study to evaluate the effect of itraconazole or fluvoxamine on MEN1611

Menarini Richerche S.p.A.0 个研究点目标入组 44 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

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•1. Be able to understand the study procedures and agree to participate in the
•study by giving written informed consent prior to any Study related activity
•(including screening) is performed.
•2. Healthy males and healthy sterile or postmenopausal females aged 18 to 65
•3. BMI between >=18.5 kg/m2 and <30 kg/m2 with a body weight >50 kg.
•4. Considered by the Investigator to be in good health as judged for
•participation in this study as determined during the medical history review,
•physical examination, vital signs, ECG and clinical laboratory.
•5. Haematology and biochemistry without clinically significant abnormalities at
•Screening. NOTE: ALT, AST, GGT, fasting glucose and glycosylated haemoglobin
•(HbA1c) must be within the Upper Limit of Normal (ULN).

•1. Females of childbearing potential, pregnant or breastfeeding.
•2. Females postmenopausal for less than 1 year (FSH levels of <=33.4 IU/L) or
•receiving hormone replacement therapy (HRT).
•3. Subjects with history of allergic, idiosyncratic or hypersensitivity
•reactions to fluvoxamine, itraconazole or to any component of MEN1611 and
•fluvoxamine and itraconazole formulations.
•4. History or clinical evidence of any illness that might pose a risk to the
•subject or interfere with the study procedures or the integrity of the study or
•interfere with interpretation of data. In particular history or clinical
•manifestations of metabolic (including type 1 and 2 diabetes), hepatic, renal,
•haematological, pulmonary, cardiovascular, endocrine, gastrointestinal,
•urological, neurological (including convulsive disorders), major psychiatric
•disorders (including mood disorders and obsessive-compulsive disorders),
•chronic skin conditions, chronic eye disorders (except for myopia,
•hypermetropia and astigmatism) or cancer.
•5. History of risk factors for torsades de pointes, including unexplained
•syncope, known long QT syndrome, heart failure, myocardial infarction, angina.
•Subjects will also be excluded if there is a family history of long QT syndrome
•or Brugada syndrome or unexplained sudden death.

发起方

Menarini Richerche S.p.A.