None listed
Conditions
Brief summary
The purpose of this study is to determine if everolimus alone or in combination with BEZ235 enhances the response to influenza vaccination in subjects >= 65 years of age who are at increased risk of influenza illness.
Interventions
Everolimus (oral tablets) alone or together with BEZ235 (oral capsules) and corresponding placebo oral tablets and oral capsules will be dosed on a once daily basis. Subjects will be randomized to receive placebo, or 0.1 mg everolimus alone or in a combination of 0.1 mg everolimus and 10 mg BEZ235 once daily for either 4 weeks (Group A) or 6 weeks (Group B).
Group A (receive influenza vaccination at baseline and start dosing after vaccination at baseline visit for a period of 4 weeks. Total
Everolimus (oral tablets) alone or together with BEZ235 (oral capsules) and corresponding placebo oral tablets and oral capsules will be dosed on a once daily basis. Subjects will be randomized to receive placebo, or 0.1 mg everolimus alone or in a combination of 0.1 mg everolimus and 10 mg BEZ235 once daily for either 4 weeks (Group A) or 6 weeks (Group B). Group A (receive influenza vaccination at baseline and start dosing after vaccination at baseline visit for a period of 4 weeks. Total treatment period is 4 weeks) I. Everolimus 0.1 mg or matched placebo II. Everolimus 0.1 mg plus 10 mg BEZ235 (combination) or matched placebo Group B (receive study drug for 2 weeks starting at the baseline visit and then receive influenza vaccination at week 2 and then continue dosing for an additional 4 weeks. Total treatment period is 6 weeks). III. Everolimus 0.1 mg or matched placebo IV. Everolimus 0.1 mg plus 10 mg BEZ235 (combination) or matched placebo Subjects will then be followed for 1 week off study drug. Compliance will be assessed by the investigator and/or study personnel at each visit by having subjects bring remaining study drug to each visit and having the site staff count the remaining number of capsules and/or tablets and having this information recorded in the eCRF.
Sponsors
resTORbio Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female subjects a. Age greater than or equal to 85 years b. Age greater than or equal to 65 years and < 85 years with one or more of the following conditions i. Asthma ii. COPD Gold Class I or II iii. T2DM iv. CHF New York Heart Association functional classification I-II v. Current smoker vi. One or more emergency room visits or hospitalizations for a RTI during the previous 12 months
Exclusion criteria
1. The following cardiac conditions: a. Unstable angina pectoris or acute ischemic changes on ECG at screening. b. History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) within 6 months prior to screening. c. Ventricular arrhythmias except for benign premature ventricular contractions d. Supraventricular and nodal arrhythmias not controlled with medication or a pacemaker. e. Symptomatic pericarditis. f. New York Heart Association functional classification III-IV CHF. g. History of familial long QT syndrome or known family history of Torsades de Pointes. 2. History of malignancy in any organ system. 3. Subjects with active infection. 4. Subjects with Type I diabetes mellitus. 5. Subjects with clinically significant underlying pulmonary disease. 6. Subjects with a history of a systemic autoimmune disease or receiving immunosuppressive therapy including prednisone > 10 mg for chronic use, 7. Recent major surgery (such as involving entry into a body cavity) within 2 months of the screening visit or any evidence of unhealed surgical wound or lack of significant recovery from the surgery.
Outcome results
None listed