None listed
Conditions
Brief summary
The purpose of this study is to determine if RTB101 helps decrease the percentage and rate of clinically symptomatic respiratory illness that are either confirmed by laboratory test or not. The study will also find out whether it decreases the duration of moderate and severe symptoms due to all clinically symptomatic respiratory illness that are confirmed with a laboratory test. The study will also see if RTB101 is safe to use. The study will also look at rate of respiratory illnesses that occur with specific viruses.
Interventions
Subjects meeting study eligibility criteria will be randomized 1:1 to receive RTB101 (dactolisib) 10 mg or matching placebo once daily for 16 weeks. The RTB101 drug product or matching placebo is a capsule for oral intake.
In order to assure subject’s compliance with the interventions drug capsule return is monitored by the site’s study team members at every visit during the treatment phase at visits week 2, week 4, week 6,week 8, week 12 and week 16. Furthermore subjects are required to documen
Subjects meeting study eligibility criteria will be randomized 1:1 to receive RTB101 (dactolisib) 10 mg or matching placebo once daily for 16 weeks. The RTB101 drug product or matching placebo is a capsule for oral intake. In order to assure subject’s compliance with the interventions drug capsule return is monitored by the site’s study team members at every visit during the treatment phase at visits week 2, week 4, week 6,week 8, week 12 and week 16. Furthermore subjects are required to document study drug administration by recording time and date into the electronic diary provided. A respiratory symptom questionnaire is required to be answered on a daily basis using this eDiary, too. The sites will have access to the subjects’ adherence to the eDiary completion rate and can remind/re-educate subjects about the need to complete and how to complete the eDiary if they forget or cannot access their eDiary. The study will be composed of up to a 4-week screening period, a 16-week treatment period and a 1-week follow-up period off study drug. There will also be a long term follow-up by telephone at Week 48. At the same time points laboratory testings (Hematology, Blood Chemistry, Urinalysis) and measurement of body weight and vital signs are performed. Until the week 12 visit a targeted physical examination is performed by the Principal Investigators at site. A complete physical examination is performed at both the screening visit and at the week 16 visit.
Sponsors
INC Research Australia Pty Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Subjects eligible for inclusion in this study must fulfill all of the following criteria: 1. Written informed consent must be obtained before any assessment is performed. 2. Male and female subjects who in the clinical judgement of the Investigator are without unstable medical conditions (as determined by medical history, electrocardiogram (ECG) and laboratory tests at Screening, and physical examination and vital signs at Screening and Baseline). 3. Subjects must be 65 years of age or older 4. Subjects who need no or minimal assistance with self-care and activities of daily living. Subjects in assisted-living or long-term care residential facilities that provide minimal assistance are eligible 5. Females must be post-menopausal. Women are considered post-menopausal and not of child bearing potential if they have had: • 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) OR • surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment will she be considered not of child bearing potential. 6. 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 with a partner of child-bearing potential to prevent delivery of the drug via seminal fluid. 7. Subject must weigh at least 40 kg. 8. Subject must be able to communicate well with the Investigator, and to understand and comply with the requirements of the study including completing a daily eDiary at home.
Exclusion criteria
Subjects will not be eligible if they meet any of the following criteria: 1. Any subject who: a. Is a current smoker as assessed by medical history or a positive cotinine test at Screening. b. Stopped smoking less than or equal to 1 year prior to screen c. Is a previous smoker with a more than or equal to 10 pack year smoking history d. Has any household member who smokes more than or equal to 1 pack per day of cigarettes 2. Subjects with a medical history of clinically significant lung diseases other than asthma (e.g., chronic obstructive pulmonary disease (COPD), emphysema, interstitial pulmonary fibrosis (IPF), bronchiectasis, etc.). 3. Subjects with a Mini Mental Status Examination (MMSE) score less than 24 at Screening. 4. Subjects with current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, renal (including subjects with an eGFR less than or equal to 50 mL/min/1.73m2), hematologic or other medical disorder. 5. The following cardiac conditions: a. Unstable angina pectoris or acute ischemic changes on ECG during Screening. b. History of myocardial infarction (MI), coronary bypass surgery, or any percutaneous coronary intervention (PCI) within 6 months prior to Screening. c. New York Heart Association functional classification III-IV congestive heart failure. d. Unstable or life-threatening cardiac arrhythmia. 6. Subjects with history of malignancy in any organ system within the past 5 years, EXCEPT for the following: a. Localized basal cell or squamous cell carcinoma of the skin. b. Prostate cancer confined to the gland (AJCC stage T2N0M0 or better). c. Cervical carcinoma in situ. d. Breast cancer localized to the breast. 7. Any respiratory tract infection or acute significant illness (based on the subject’s medical history and the clinical judgement of the Investigator) which has not resolved at least two (2) weeks prior to initial dosing. 8. Subjects with a history of a systemic autoimmune diseases (e.g., lupus, inflammatory bowel disease, rheumatoid arthritis, etc.), or receiving immunosuppressive therapy including chronic use of prednisone more than 10 mg daily (however, acute use of higher doses of prednisone to treat conditions such as exacerbation of asthma or other acute conditions is allowed). 9. Subjects with Type I diabetes mellitus. 10. Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further evaluation. 11. Subjects with any one of the following during Screening: a. white blood cell (WBC) count less than 2000/mL. b. neutrophil count less than 1000/mL. c. platelet count less than 7500/mL.. 12. Subjects with a history of alcohol or drug abuse within 2 years of the Screening visit. 13. Subjects with any conditions affecting absorption, distribution, or metabolism of the study drug (e.g., inflammatory bowel disease, gastric or duodenal ulcers, or hepatic disease). For patients with biochemical evidence of liver injury as indicated by abnormal liver function tests: • Any single parameter of ALT, AST, alkaline phosphatase or serum bilirubin must not exceed 1.5 x upper limit of normal (ULN) • Any elevation above ULN of more than one parameter of ALT, AST, alkaline phosphatase or serum bilirubin will exclude a subject from participation in the study. 14. Subjects with a history of immunodeficiency diseases, including a positive human immunodeficiency virus (HIV) test result. 15. Infection with Hepatitis B virus (HBV) or Hepatitis C virus (HCV). 16. Subjects who require treatment with strong CYP3A4 or CYP1A2 inhibitors or inducers or subjects who require treatment with digoxin. 17. Use of an investigational medication or participation in an investigational study within 5 half-lives of the investigational medication, or within 30 days, whichever is longer; or longer if required by local regulations. Subjects previously treated with RTB101 and/or everolimus in study CBEZ235Y2201, RTB-BEZ235-202, or RTB-BEZ235-203 will be eligible to participate in this study if they meet all other inclusion and exclusion criteria.
Outcome results
None listed