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

Respiratory Syncytial Virus Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02673476
• Other study ID #: ALS-8176-510
• Status: Completed
• Phase: Phase 2
• First received: January 29, 2016
• Last updated: October 23, 2017
• Start date: February 29, 2016
• Est. completion date: October 31, 2016

Study information

• Verified date: October 2017
• Source: Alios Biopharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: October 31, 2016
• Est. primary completion date: October 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections
• Virus Diseases

Intervention

Drug:
• ALS-008176
ALS-008176 tablets
• Placebo
Identical placebo tablets

Locations

Country	Name	City	State
Australia	Cairns Hospital	Cairns	Queensland
Australia	Monash Heal.-Monash Lung&Sleep	Clayton	Victoria
Australia	Westmead Hospital	Northmead	New South Wales
Australia	The Royal Melbourne Hospital	Parkville	Victoria
Australia	Mater Adult Hospital	South Brisbane	Queensland
Australia	The Queen Elizabeth Hospital	Woodville South	South Australia
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
New Zealand	Wellington Regional Hospital	Newtown	Wellington
Singapore	Raffles Hospital	Singapore
Taiwan	Taipei Med. Uni-Shuang Ho Hosp	New Taipei City
United States	Infectious Disease Specialists of Atlanta	Atlanta	Georgia
United States	University of Missouri- Clinical Research Center	Columbia	Missouri
United States	Lake Internal Med. Assoc.	Eustis	Florida
United States	Kentucky Lung Clinic, PSC	Hazard	Kentucky
United States	The Research Center, Inc.	Hialeah	Florida
United States	Bronson Methodist Hosp. Ped	Kalamazoo	Michigan
United States	JDH Medical Group LLC	Miami	Florida
United States	St Lucie Medical Center	Port Saint Lucie	Florida
United States	Washington Univ School of Med	Saint Louis	Missouri
United States	Tampa Genereal Hospital	Tampa	Florida
United States	William Beaumont Hospital	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Alios Biopharma Inc.

Countries where clinical trial is conducted

United States,  Australia,  New Zealand,  Singapore,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC of RSV RNA	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.	From prior to first dose to study day 7
Secondary	Time from baseline to non-detectability of RSV from nasal swab	Time from baseline to non-detectability of RSV from nasal swab	From prior first dose to study day 28
Secondary	Percent of subjects with undetectable RSV by qPCR	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	From study day 3, and every two days until study day 7
Secondary	Peak post-baseline viral load	Peak post-baseline viral load from nasal swab	From before first dose to study day 28
Secondary	Rate of decline from baseline in viral load during treatment from nasal swab	Rate of decline from baseline in viral load during treatment from nasal swab	From before first dose to study day 2
Secondary	Duration of hospital stay	Duration of hospital stay	From first dose to study day 28
Secondary	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	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).	From screening to study day 28
Secondary	PK parameters: Cmax	PK parameters in plasma following repeat dose administration: Cmax	From first dose to study day 28
Secondary	PK parameters: tmax	PK parameters in plasma following repeat dose administration: tmax	From first dose to study day 28
Secondary	PK parameters: AUClast	PK parameters in plasma following repeat dose administration: AUClast	From first dose to study day 28
Secondary	PK parameters: t1/2	PK parameters in plasma following repeat dose administration: t1/2	From first dose to study day 28
Secondary	PK parameters: AUC0 tau	PK parameters in plasma following repeat dose administration: AUC0 tau	From first dose to study day 28