EUCTR2012-000299-40-Outside-EU/EEAActive, not recruitingPhase 1
A randomized, open label, two-way crossover study investigating the relative bioavailability of a single 5 mg dose of everolimus administered as either 5x1 mg everolimus intact tablets or 5x1 mg everolimus tablets suspended in 30 mL of water to healthy subjects
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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.
Investigators
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