None listed
Conditions
Brief summary
A multicenter study to see if everolimus has an effect on the immune response in elderly people.
Interventions
Elderly participants who meet eligibility during the 21 day screening period will be randomised to 1 of the treatment arms:
Arm 1 Evrolimus 0.5 mg by mouth daily or unmatched placebo
Arm 2 Everolimus 5 mg by mouth weekly or matched placebo
Arm 3 Everolimus 20 mg by mouth weekly or unmatched placebo
During the screening period the Study Doctor will ask you about your health and your medical and (psychiatric) history. The doctor will do a physical exam and measure your height, weight, blood pres
Elderly participants who meet eligibility during the 21 day screening period will be randomised to 1 of the treatment arms: Arm 1 Evrolimus 0.5 mg by mouth daily or unmatched placebo Arm 2 Everolimus 5 mg by mouth weekly or matched placebo Arm 3 Everolimus 20 mg by mouth weekly or unmatched placebo During the screening period the Study Doctor will ask you about your health and your medical and (psychiatric) history. The doctor will do a physical exam and measure your height, weight, blood pressure, heart rate and breathing rate. You will be asked about any medications you have been taking. You will have a heart tracing (electrocardiogram [ECG]) and blood and urine will be taken for laboratory testing. You will have a chest X-ray done if you haven’t had one in the last 3 months.
Sponsors
Novartis Institutes for BioMedical Research, Inc.
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Male and female (postmenopausal or surgically sterile). Subjects must weight at least 40kg to participate.
Exclusion criteria
Subjects with underlying unstable medical conditions.
Outcome results
None listed