Cancer with PIK3CA mutation Cancer tumors
Conditions
Interventions
In total the volunteer will receive 2 doses of MEN1611.
Each dose will be 48 mg and will be given as 3 capsules of 16 mg each.
Itraconazole group will receive MEN1611 on Day 1 and on Day 12.
Fluvoxa
Sponsors
Menarini Richerche S.p.A.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 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 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).
Exclusion criteria
Exclusion criteria: 1. Females of childbearing potential, pregnant or breastfeeding. 2. Females postmenopausal for less than 1 year (FSH levels of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of CYP3A4/P-gp (itraconazole) or CYP1A2/3A4 (fluvoxamine) inhibition on the PK of MEN1611 single-dose in healthy subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To evaluate the effect on the electrocardiographic parameters in healthy subjects of MEN1611 single-dose alone and in presence of a CYP3A4/P-gp inhibitor (itraconazole) or a CYP1A2/3A4 inhibitor (fluvoxamine). - To assess the safety and tolerability of MEN1611 in healthy volunteers when co-administered with a CYP3A4/P-gp inhibitor (itraconazole) or with a CYP1A2/3A4 inhibitor (fluvoxamine). | — |
Countries
Netherlands
Outcome results
None listed