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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02202356 |
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Date of registration:
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23/07/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of ALS-008176 in Infants Hospitalized With RSV
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Scientific title:
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A Randomized, Double-blind, Placebo-controlled, 2-Part Study of Orally Administered ALS-008176 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Dosing and Multiple Ascending Dosing in Infants Hospitalized With Respiratory Syncytial Virus (RSV) Infection |
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Date of first enrolment:
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July 23, 2014 |
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Target sample size:
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183 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02202356 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 1
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Countries of recruitment
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Australia
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Canada
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Chile
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Colombia
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France
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Japan
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New Zealand
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Panama
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Romania
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South Africa
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Taiwan
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Thailand
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United Kingdom
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United States
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Contacts
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Name:
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Matthew McClure, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Alios BioPharma |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female infant who is =1.0 to =12.0 months of age (inclusive), defined at the
time of hospital admission, or <28 days of age (neonate cohort only). Note: all
subjects, including neonates, must have been discharged from the hospital after birth
and are now being admitted due to an RSV related illness
Exclusion Criteria:
- Prematurity
- Receiving invasive endotracheal mechanical ventilation
- Poorly functioning gastrointestinal tract
- Anticipated to be discharged from the hospital in <24 hours from the time of
randomization
- Prior exposure to palivizumab
Age minimum:
N/A
Age maximum:
12 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Respiratory Syncytial Virus Infections
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Intervention(s)
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Drug: Placebo
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Drug: ALS-008176
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Primary Outcome(s)
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Vital Signs
[Time Frame: Baseline through 6 days post-dose]
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12-Lead ECGs
[Time Frame: Baseline through 6 days post-dose]
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Clinical Laboratory Results
[Time Frame: Baseline through 6 days post-dose]
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Physical Examinations
[Time Frame: Baseline through 6 days post-dose]
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Adverse Events
[Time Frame: Baseline through 6 days post-dose]
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Secondary Outcome(s)
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Pharmacokinetic parameters, including time to maximum concentration and half-life
[Time Frame: Baseline through 6 days post-dose]
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Pharmacokinetic parameters, including area under concentration-time curves (AUCs)
[Time Frame: Baseline through 6 days post-dose]
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Pharmacokinetic parameters, including apparent oral clearance (CL/F) and apparent volume of distribution at steady state (VDss/F)
[Time Frame: Baseline through 6 days post-dose]
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Emergence of resistance
[Time Frame: Baseline through 6 days post-dose]
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RSV viral RNA concentrations in nasal aspirates
[Time Frame: Baseline through 6 days post-dose]
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Pharmacokinetic parameters, including maximum and minimum drug concentrations
[Time Frame: Baseline through 6 days post-dose]
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Secondary ID(s)
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2013-005104-33
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ALS-8176-503
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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