Healthy volunteers
Conditions
Interventions
Product Name: Everolimus
Product Code: RAD001
Pharmaceutical Form: Tablet
INN or Proposed INN: Everolimus
CAS Number: 159351-69-6
Current Sponsor code: RAD001
Other descriptive name: EVEROLIMUS
Concen
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Female or male healthy subjects from 18 to 55 years of age; • Female subjects must be postmenopausal (no menstrual bleeding for 12 months), or surgically sterilized at least 6 months prior to screening; • Good health status as determined by past medical history, physical examination, vital signs, electrocardiogram and laboratory tests within normal ranges at screening; • Vital signs (after 3 minutes resting measured in the supine position) must be within the ranges specified in the protocol 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 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Smokers defined as having used tobacco products in the previous 3 months or having urine cotinine levels greater than 500 ng/mL tested at screening and each baseline visit; • Use of any prescription medication within 1 month prior to dosing or any over-the-counter (OTC) medication within 2 weeks prior to dosing; • Consumption of grapefruit products within 1 week prior to dosing; • Participation in any clinical investigation within 4 weeks prior to dosing; • Donation or loss of 450 mL or more of blood within 56 days prior to dosing; • Women who are of child-bearing potential, or pregnant, or breast feeding (positive serum pregnancy test for ß-hCG at screening and each baseline visit); • A known hypersensitivity to rapamycins and their derivates or drugs similar to RAD001, e.g. macrolides; • Any subject who has been diagnosed with type I or II diabetes, hyperglycemia or impaired glucose intolerance; • History of any significant respiratory system chronic brochospastic disease (including asthma and COPD, treated or not treated). • History of atopic allergy (asthma, urticaria, eczematous dermatitis); • Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the subject in case of participation in the study. • History of immunosuppression, including a known positive HIV test result; • A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result; • Evidence of alcohol and drug usage as indicated by laboratory assays performed at screening and prior to baseline period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the bioavailability of: 5 x 1 mg everolimus intact tables, and 5 x 1 mg everolimus tablets suspended in 30 mL of water;Secondary Objective: To evaluate the safety and tolerability of the 1 mg everolimus tablets administered as suspension and as intact tablets;Primary end point(s): Primary pharmacokinetic parameters: AUC(0-t), AUC(0-inf) and Cmax;Timepoint(s) of evaluation of this end point: Full pharmacokinetic whole blood samples will be drawn at each of the two treatment periods as follows: 1 pre-dose sample < 15min prior to administration of study drug and 17 postdose samples at 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h and 144 h after administration of study drug. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Secondary pharmacokinetic parameters: Tmax, ?z, Vd/F, CL/F and t1/2 - Safety endpoints (evaluation of adverse events and serious adverse events, vital signs, ECG, laboratory results (hematology, blood chemistry, urinalysis);Timepoint(s) of evaluation of this end point: - Full pharmacokinetic whole blood samples will be drawn at each of the two treatment periods as follows: 1 pre-dose sample < 15min prior to administration of study drug and 17 postdose samples at 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 36 h, 48 h, 72 h, 96 h, 120 h and 144 h after administration of study drug. - Safety laboratory assessments will be performed regularly. Hematology and biochemistry laboratory parameters will be evaluated at screening, each of the 2 baseline visits, 144 hours post-dose and at the study completion visit. | — |
Countries
United States
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed