None listed
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy, tolerability and safety of BEZ235 alone or in combination with RAD001 in reducing the incidence of RTIs in elderly subjects at increased risk of RTI-related morbidity or mortality.
Interventions
The study will be conducted in two parts.
PART 1
Eligible participants will be randomized to 1 of 3 treatment groups in a ratio of 1:1:1.
Group 1: oral BEZ235 5 mg capsules taken once daily for 16 weeks
Group 2: oral BEZ235 10 mg capsules daily taken once daily for 16 weeks
Group 3: oral Matched placebo capsules taken once daily for 16 weeks
PART 2
Group 1: Chosen oral BEZ235 capsule dose from Part 1 (dose showing greatest efficacy with good tolerability) taken once daily for 16 weeks
Group 2:
The study will be conducted in two parts. PART 1 Eligible participants will be randomized to 1 of 3 treatment groups in a ratio of 1:1:1. Group 1: oral BEZ235 5 mg capsules taken once daily for 16 weeks Group 2: oral BEZ235 10 mg capsules daily taken once daily for 16 weeks Group 3: oral Matched placebo capsules taken once daily for 16 weeks PART 2 Group 1: Chosen oral BEZ235 capsule dose from Part 1 (dose showing greatest efficacy with good tolerability) taken once daily for 16 weeks Group 2: oral BEZ235 10 mg capsule + oral RAD001 0.1 mg tablets taken once daily for 16 weeks Group 3: oral Placebo capsule taken once daily for 16 weeks Part 2 will be conducted in the Northern Hemisphere with a different set of participants. all medications to be given to participants will be Adherence to the treatment will be monitored by reviewing patient diary entries and monitoring returned treatment bottles.
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 without unstable medical conditions as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening and A. Age 85 years and above or B. Age 65 years and above with one or more of the following conditions: a. Current smoker b. COPD Gold Class I or II (post bronchodilator FEV1/FVC < 0.70 and FEV1 less than or equal to 50% predicted) c. Asthma d. Chronic bronchitis e. CHF New York Heart Association functional classification I-II f. T2DM g. One or more emergency room visits or hospitalizations for a RTI during the previous 12 months 2. Females must be post-menopausal 3. Sexually active male subjects with a partner of child-bearing potential must be willing to wear a condom while on study drug and for 1 week after stopping study drug, and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid 4. At screening and baseline, vital signs (systolic and diastolic blood pressure, pulse rate and respiratory rate) will be assessed in a sitting position after the subject has rested for at least three (3) minutes. Sitting vital signs should be within the following ranges: a. oral body temperature between 35.0-37.5 degrees Celsius b. systolic blood pressure, 90-160 mm Hg c. diastolic blood pressure, 50-95 mm Hg d. pulse rate, 40 - 95 bpm 5. Subjects must weigh at least 40 kg
Exclusion criteria
1. History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) within 6 months prior to Screening 2. New York Heart Association functional classification III-IV congestive heart failure 3. Subjects with Type I diabetes mellitus 4. Subjects with clinically significant underlying pulmonary disease other than asthma, GOLD Class I and II COPD or chronic bronchitis 5. Subjects with a history of a systemic autoimmune disease or receiving immunosuppressive therapy including prednisone > 10 mg po daily 6. Any history of coagulopathy or medical condition requiring long-term anti-coagulation (low-dose aspirin treatment or equivalent is allowed) The protocol has the full list of exclusion criteria
Outcome results
None listed