Respiratory Syncytial Virus (RSV) MedDRA version: 21.1 Level: PT Classification code 10061603 Term: Respiratory syncytial virus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: EDP-938
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: not available
CAS Number: 2070852-76-3
Current Sponsor code: EDP-938
Other descriptive name: EP-023938, EP-39
Sponsors
Enanta Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female who is either =6 months to =36 months (for Age Group 1) or =28 days to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Use of or anticipated need for invasive mechanical ventilation, cardiopulmonary bypass, hemodialysis, or extracorporeal membrane oxygenation; or subjects who are not expected to survive the current illness 2. Subjects who have a medical history or a concurrent illness that in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject, or that could prevent, limit, or confound the protocol-specified assessments. Examples include liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic conditions 3. Subjects who are considered unable to take study drug orally, by mouth, nasogastric tube, or orogastric tube (e.g., as a consequence of acute respiratory distress, or unable to absorb study drug enterally) 4. Subjects who have received blood products within 6 months of study drug administration 5. Subjects with underlying immune deficiency, e.g., from confirmed human immunodeficiency virus infection or use of an immunosuppressive medication except immunoglobulin A deficiency 6. Subjects who received (within 12 months before Screening) or who are currently on a waiting list for a bone marrow, stem cell, or solid organ transplant, or who received radiation or chemotherapy (within 12 months before screening) 7. Subjects who have had major surgery in the 6 weeks before randomization 8. Subject receiving chronic oxygen therapy at home before admission 9. Subjects who are being breastfed by a mother taking any of the excluded medications 10. Subjects whose mother received a RSV vaccination while pregnant with the subject if they were born at term (=37 weeks of gestation) and are less than 12 months of age; 11. Receipt of systemic antiviral, antifungal, or antimycobacterial therapy within 7 days of Screening 12. Subjects who received systemic medications other than corticosteroids (either chronically [more than 14 days] or within 21 days before randomization) that are known to modulate the host’s immune response or increase viral shedding, such as immunomodulatory therapies. Systemic corticosteroids are not prohibited in Part 1 13. In Part 2, subjects dosed with an investigational or approved medication that is intended to prevent or treat RSV infection within the following times before the first dose of study drug: • ribavirin: 35 days, • palivizumab: 100 days, • nirsevimab: 350 days, • other RSV-specific monoclonal antibody: 5 half-lives of specific antibody, • RSV vaccines: 12 months. 14. Use of or intention to use any medication or supplement known to be a moderate or strong inducer or inhibitor of the cytochrome P450 3A4 enzyme within 14 days before the first dose of study drug 15. Subjects who are enrolled in another investigational drug or vaccine study 16. Known allergy/hypersensitivity or intolerance to EDP-938, placebo or their excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part 1 • To evaluate the PK of EDP-938 • To assess the safety and tolerability of EDP-938 Part 2 • To evaluate the antiviral activity of EDP-938 ;Secondary Objective: Part 1 • To evaluate the antiviral activity of EDP-938 Part 2 • To assess the safety and tolerability of EDP-938 • To evaluate the PK of EDP-938 • To evaluate additional antiviral activity measures of EDP-938 • To evaluate clinical outcomes of EDP-938;Primary end point(s): Part 1 1) PK parameters of EDP-938 including area under the curve (AUC) and predose concentrations 2) Safety and tolerability of EDP-938 compared to placebo as assessed by, but not limited to, AEs, vital signs, and clinical laboratory results Part 2 1) Daily change in RSV shedding in nasal swab samples determined using qPCR from before the first dose of study drug (Baseline) through treatment phase;Timepoint(s) of evaluation of this end point: Part 1 1) From Day 1 up to 10 hours post Day 5 dose 2) From baseline up to Day 28 Part 2 1) From baseline up to Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Part 1 1) AUC for RSV RNA viral load measured in nasal swab samples by quantitative reverse transcription polymerase chain reaction (RT-qPCR) 2) Daily change in RSV shedding in nasal swab samples determined using RT-qPCR from before the first dose of study drug (Baseline) through the treatment phase 3) Proportion of subjects with RSV RNA viral load below the limit of detection (LOD) in subjects receiving EDP-938 compared to placebo 4) Time to RSV RNA viral load being undetectable Part 2: 1) Safety and tolerability of EDP-938 compared to placebo as assessed by, but not limited to, AEs, vital signs, and clinical laboratory results 2) AUC for RSV RNA viral load measured in nasal swab samples by RT-qPCR 3) Proportion of subjects with RSV RNA viral load below the LOD in subjects receiving EDP-938 compared to placebo 4) Time to RSV RNA viral load being undetectable 5) PK parameters of EDP-938 including AUC and predose concentrations 6) Time to discharge for hospitalized subjects; 7) Time to use of oxygen for hospitalized subjects who are not receiving oxygen at the time they receive the first dose of study drug; 8) Proportion of hospitalized subjects requiring oxygen supplementation or have an increased oxygen requirement 9) Time to mechanical ventilation for hospitalized subjects; 10) Proportion of hospitalized subjects requiring mechanical ventilation; 11) Deaths among hospitalized subjects; 12) Time to hospitalization for initial outpatients who are subsequently hospitalized; 13) Proportion of outpatients who are subsequently hospitalized or died; 14) Time to resolution of symptoms for outpatients who are not hospitalized;Timepoint(s) of evaluation of this end point: Part 1: 1) From baseline up to Day 14 2) From baseline up to Day 14 3) From baseline up to Day 14 4) From baseline up to Day 14 Part 2: 1) From baseline up to Day 28 2) From baseline up to Day 14 3) From baseline up to Day 14 4) From baseline up to Day 14 5) From Day 1 up to 10 | — |
Countries
Argentina, Australia, Brazil, Germany, Israel, Korea, Republic of, Mexico, New Zealand, Poland, Romania, South Africa, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactMaria Gawryl
Enanta Pharmaceuticals, Inc.
Outcome results
None listed