Clinical trial NCT02673476: A Phase 2a Study to Evaluate Orally Administered ALS-008176 in Adults Hospitalized With a Respiratory Syncytial Virus
Official title: A Phase 2a, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Orally Administered ALS-008176 in Adults Hospitalized With a Respiratory Syncytial Virus-Related Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Respiratory Syncytial Virus Infections
Lead sponsor: Alios Biopharma Inc.
Sponsor class: INDUSTRY
First posted: 2016-02-04
Enrollment: 9
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being to see how effective and safe ALS-008176 is in treating adults in the hospital with a Respiratory Syncytial Virus-Related Illness.


Eligibility 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.

Exclusion Criteria:

1. Subject is undergoing peritoneal dialysis, hemodialysis or hemofiltration or has an estimated glomerular filtration rate (GFR, determined by Cockcroft-Gault Formula) \<30 mL/min.
2. Subject has presence of any concurrent illness, including laboratory, vital sign, ECG, or physical exam findings, or medical history that, in the opinion of the investigator, would place the subject at an unreasonably increased risk as a result of participation in this study.
3. Subject reports receiving an investigational drug or vaccine within 30 days, or 5 half-lives (whichever is longer) prior to the planned first dose of study drug.
4. Subject has a known history of human immunodeficiency virus (HIV) or chronic, active hepatitis infection.
5. ALT \>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 \<24 hours after randomization.
8. Subjects who are not expected to survive for \<48 hours.
9. Recent (\<5 half-lives) use, or anticipated use during conduct of the study, of concomitant medications (prescription and non-prescription) which are inhibitors of the OAT3 transporter.
10. Treatment of the current illness with drugs specifically targeting the RSV infection itself (e.g., RSV immunoglobulin, ribavirin, palivizumab). Medications treating the sequelae of the RSV infection or any concurrent illness are permitted if not otherwise excluded.
11. Subjects unwilling to undergo regular nasal swab procedures or with any physical abnormality which limits the ability to collect regular nasal specimens.
12. Subjects that are considered by the investigator to be immunocompromised over the past 12 months, whether due to underlying medical condition or medical therapy.
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 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, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide).

Primary outcomes:
measure: AUC of RSV RNA
timeFrame: From prior to first dose to study day 7
Secondary outcomes:
measure: Time from baseline to non-detectability of RSV from nasal swab
timeFrame: From prior first dose to study day 28
measure: Percent of subjects with undetectable RSV by qPCR
timeFrame: From study day 3, and every two days until study day 7
measure: Peak post-baseline viral load
timeFrame: From before first dose to study day 28
measure: Rate of decline from baseline in viral load during treatment from nasal swab
timeFrame: From before first dose to study day 2
measure: Duration of hospital stay
timeFrame: From first dose to study day 28
measure: Safety data: Composite number and frequency of treatment emergent adverse events, physical examination findings, abnormal vital signs, 12 lead ECG, echo and abnormal clinical laboratory results
timeFrame: From screening to study day 28
measure: PK parameters: Cmax
timeFrame: From first dose to study day 28
measure: PK parameters: tmax
timeFrame: From first dose to study day 28
measure: PK parameters: AUClast
timeFrame: From first dose to study day 28
measure: PK parameters: t1/2
timeFrame: From first dose to study day 28
measure: PK parameters: AUC0 tau
timeFrame: From first dose to study day 28
Other outcomes:
Locations:
city: Eustis
country: United States
facility: Lake Internal Med. Assoc.
state: Florida
city: Hialeah
country: United States
facility: The Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: JDH Medical Group LLC
state: Florida
city: Port Saint Lucie
country: United States
facility: St Lucie Medical Center
state: Florida
city: Tampa
country: United States
facility: Tampa Genereal Hospital
state: Florida
city: Atlanta
country: United States
facility: Infectious Disease Specialists of Atlanta
state: Georgia
city: Hazard
country: United States
facility: Kentucky Lung Clinic, PSC
state: Kentucky
city: Kalamazoo
country: United States
facility: Bronson Methodist Hosp. Ped
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Columbia
country: United States
facility: University of Missouri- Clinical Research Center
state: Missouri
city: Saint Louis
country: United States
facility: Washington Univ School of Med
state: Missouri
city: Northmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Cairns
country: Australia
facility: Cairns Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Adult Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Clayton
country: Australia
facility: Monash Heal.-Monash Lung&Sleep
state: Victoria
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Newtown
country: New Zealand
facility: Wellington Regional Hospital
state: Wellington
city: Singapore
country: Singapore
facility: Raffles Hospital
city: New Taipei City
country: Taiwan
facility: Taipei Med. Uni-Shuang Ho Hosp
Study officials:
affiliation: Alios Biopharma Inc.
name: Abbie Oey
role: STUDY_DIRECTOR
References: