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A Phase 2a Study to Evaluate Orally Administered ALS-008176 in Adults Hospitalized With a Respiratory Syncytial Virus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02673476
Recruitment Status : Completed
First Posted : February 4, 2016
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
Alios Biopharma Inc.

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.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infections Drug: ALS-008176 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : February 29, 2016
Actual Primary Completion Date : October 31, 2016
Actual Study Completion Date : October 31, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Identical Placebo Comparator
Drug: Placebo
Identical placebo tablets

Experimental: ALS-008176
ALS-008176 tablets
Drug: ALS-008176
ALS-008176 tablets




Primary Outcome Measures :
  1. AUC of RSV RNA [ Time Frame: From prior to first dose to study day 7 ]
    Area under the curve (AUC) of RSV ribonucleic acid (RNA) from nasal swabs immediately prior to 1st dose of study drug (baseline) until Day 7.


Secondary Outcome Measures :
  1. Time from baseline to non-detectability of RSV from nasal swab [ Time Frame: From prior first dose to study day 28 ]
    Time from baseline to non-detectability of RSV from nasal swab

  2. Percent of subjects with undetectable RSV by qPCR [ Time Frame: From study day 3, and every two days until study day 7 ]
    Percent of subjects with undetectable RSV by qPCR on Day 3, Day 5, and every other day until 2 days after last dose from nasal swab

  3. Peak post-baseline viral load [ Time Frame: From before first dose to study day 28 ]
    Peak post-baseline viral load from nasal swab

  4. Rate of decline from baseline in viral load during treatment from nasal swab [ Time Frame: From before first dose to study day 2 ]
    Rate of decline from baseline in viral load during treatment from nasal swab

  5. Duration of hospital stay [ Time Frame: From first dose to study day 28 ]
    Duration of hospital stay

  6. 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 [ Time Frame: From screening to study day 28 ]
    Tabulation of the number and frequency of treatment emergent adverse events, physical examination findings, abnormal vital signs, 12 lead ECG, echo and abnormal clinical laboratory results (including chemistry, hematology, and urine).

  7. PK parameters: Cmax [ Time Frame: From first dose to study day 28 ]
    PK parameters in plasma following repeat dose administration: Cmax

  8. PK parameters: tmax [ Time Frame: From first dose to study day 28 ]
    PK parameters in plasma following repeat dose administration: tmax

  9. PK parameters: AUClast [ Time Frame: From first dose to study day 28 ]
    PK parameters in plasma following repeat dose administration: AUClast

  10. PK parameters: t1/2 [ Time Frame: From first dose to study day 28 ]
    PK parameters in plasma following repeat dose administration: t1/2

  11. PK parameters: AUC0 tau [ Time Frame: From first dose to study day 28 ]
    PK parameters in plasma following repeat dose administration: AUC0 tau



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673476


Locations
Show Show 21 study locations
Sponsors and Collaborators
Alios Biopharma Inc.
Investigators
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Study Director: Abbie Oey Alios Biopharma Inc.
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Responsible Party: Alios Biopharma Inc.
ClinicalTrials.gov Identifier: NCT02673476    
Other Study ID Numbers: ALS-8176-510
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No data will be shared

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Syncytial Virus Infections
Virus Diseases
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections