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.
- Conditions
- Cancer with PIK3CA mutationCancertumors
- Registration Number
- NL-OMON51334
- Lead Sponsor
- Menarini Richerche S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 44
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
years.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To evaluate the effect of CYP3A4/P-gp (itraconazole) or CYP1A2/3A4<br /><br>(fluvoxamine) inhibition on the PK of MEN1611 single-dose in healthy subjects.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To evaluate the effect on the electrocardiographic parameters in healthy<br /><br>subjects of MEN1611 single-dose alone and in presence of a CYP3A4/P-gp<br /><br>inhibitor (itraconazole) or a CYP1A2/3A4 inhibitor (fluvoxamine).<br /><br><br /><br>- To assess the safety and tolerability of MEN1611 in healthy volunteers when<br /><br>co-administered with a CYP3A4/P-gp inhibitor (itraconazole) or with a<br /><br>CYP1A2/3A4 inhibitor (fluvoxamine).</p><br>