None listed
Conditions
Interventions
ALS-008176 will be supplied as white to off-white film coated tablets containing 250 mg and 500 mg of ALS-008176. Both strengths of active study drug have the same appearance of tablet size, shape, an
Sponsors
Alios BioPharma, Inc.,
Eligibility
Sex/Gender
All
Age
50 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Subject is ≥50 years of age. 2. Female subjects of non-childbearing potential (i.e., surgically sterilized, post-menopausal [amenorrhea for 1 year confirmed by negative hormone panel]) who also have a negative pregnancy test at screening. 3. Male subjects must be either surgically sterilized (e.g., post-vasectomy or orchiectomy) or willing to adhere to the study’s contraceptive requirements. Male subjects’ female partner(s) must be surgically sterilized or post-menopausal (amenorrhea for 1 year) or their female partner(s) of child-bearing potential must be willing and able to adhere to the contraceptive requirements. 4. Each subject or their legal guardian must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study before starting any screening activities. 5. Subject has a positive RT-PCR test result for RSV at the time of screening. NOTE: Co-infection with other acute viruses or bacteria is permitted. 6. Subject has been, or will be, admitted to the hospital for an acute respiratory illness with signs and symptoms consistent with a viral infection (e.g., fever, cough, nasal congestion, runny nose, sore throat, myalgia, lethargy, shortness of breath, or wheezing) with onset <7 days from the anticipated time of randomization. NOTE: The viral infection may present in any way so long as the underlying precipitant of the illness is considered by the PI to be due to RSV infection. Examples of such an illness include: • An upper or lower viral respiratory tract infection (e.g., “flu-like illness”) • Pneumonia • Respiratory distress • Asthma exacerbation • COPD exacerbation
Exclusion criteria
Exclusion criteria: Subjects will be ineligible for this study if they meet any one of the following criteria: 1. Subject is undergoing peritoneal dialysis, hemodialysis or hemofiltration or has an estimated glomerular filtration rate (GFR, determined by Cockcroft-Gault Formula) 3×ULN AND bilirubin >2×ULN (direct >35%) OR ALT>5×ULN 6. Subjects who have been hospitalized for >72 hours at the time of randomization. 7. Subjects anticipated to be hospitalized for 28 day) use of corticosteroids is permitted for prednisone doses ≤20 mg (or equivalent). 13. Subjects unable to take medications enterally (e.g., orally or via nasogastric or PEG tube) or a known gastrointestinal-related condition that may interfere with study drug absorption. 14. Female subject that is pregnant or breastfeeding 15. In the investigator’s opinion, the subject is unwilling or unable (e.g., due to concomitant medical conditions) to comply with protocol requirements, instructions, and protocol stated restrictions, and is unlikely to complete the study as planned. 16. Subject has known or suspected hypersensitivity to the study drug or its excipients (microcrystalline cellulose, mannitol, croscarmellose sodium,
Countries
Australia, Chile, New Zealand, Peru, Singapore, Taiwan, United States
Contacts
Public ContactElvira Mogrovejo
IQVIA RDS Peru S.R.L
Outcome results
None listed