Respiratory Syncytial Virus RSV
Conditions
Interventions
One group receives 800 mg EDP-938 once a day for 5 days, the other group
receives placebo once a day for 5 days.
EDP-938 will be supplied as tablets for oral administration in two dose
strengths: 15
Sponsors
Enanta Pharmaceuticals, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. A full ICF signed and dated by the subject. (Note: Prior to signing the full ICF, subjects will sign a Rapid Viral Screen ICF as described in inclusion criterion #4.) 2. Male or female individuals aged 18 to 75 years, inclusive. 3. Up to 48 hours of URTI symptoms with at least one of the following symptoms: Nasal discharge, nasal congestion, malaise/tiredness, headache, sinus congestion, sneezing, sore throat, hoarseness, cough, shortness of breath, respiratory wheeze, earache, and/or symptoms of fever. Note: The duration of symptoms (not more than 48 hours) is to be measured from the estimated time of onset of the first symptom. 4. After signing the Rapid Viral Screen ICF, positive for RSV infection and negative for influenza virus based on rapid diagnostic screen of nasal (or nasopharyngeal) swab samples. 5. Medically stable based on assessment of physical examination, medical history, vital sign measurements, pulse oximetry (only for subjects with asthma or COPD), and 12-lead ECG performed at Screening. 6. A body mass index >=18 kg/m2 and =3 months prior to dosing or b. Has had a bilateral oophorectomy (ovariectomy) or c. Has had a bilateral tubal ligation or fallopian tube inserts or d. Is postmenopausal (a total cessation of menses for at least 2 years; Note: Subjects with a cessation of menses between 1 to 2 years and a follicle-stimulating hormone [FSH] level of >35 mIU/mL will also be considered to be postmenopausal). 9. A male subject who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug. Effective contraception is defined as a condom and at least one of the following for a female partner: a. Intrauterine device b. Occlusive cap (diaphragm or cervical/vault caps) c. Oral, injectable, implantable, transdermal, or intravaginal contraceptive Note: For a male subject who has had a vasectomy, use of a condom will still be required. 10. Male subjects must agree to refrain from sperm donation from the date of Screening until 90 days after his last dose of study drug. 11. Must be willing and able to adhere to the study assessments, visit schedules, prohibitions, and restrictions, as described in this protocol. Additional Inclusion Criteria for Subjects With Asthma 12. Physician-diagnosed asthma and currently receiving Global Initiative for <b
Exclusion criteria
Exclusion criteria: 1. Clinical evidence of a lower respiratory tract infection, as determined by the Investigator. 2. Anticipated need for hospitalization or emergency room care within 24 hours of Screening. 3. Receipt of systemic antiviral, antibacterial, antifungal, or antimycobacterial therapy within 7 days of Screening and for the duration of the study. 4. Awareness of concomitant respiratory infections that are viral (other than RSV), bacterial, or fungal, including systemic bacterial or fungal infections, within 7 days of Screening. 5. SARS-CoV-2 positive within 28 days of Screening or at Screening following signature of full ICF. 6. Frailty scale score >=4 at Screening. 7. History of chronic liver disease (eg, hemochromatosis, Wilson*s disease, alpha-1 antitrypsin deficiency, autoimmune hepatitis, nonalcoholic steatohepatitis, and/or alcoholic liver disease); a history of biliary disease (eg, primary sclerosing cholangitis, cholecystitis, choledocholithiasis); or a history of portal hypertension. A diagnosis of hepatic steatosis (fatty liver) is not exclusionary. 8. Heart disease: any congenital heart disease, acute or chronic heart failure, ischemic heart disease, congenital long QT syndrome, or any clinical manifestation resulting in QT interval prolongation. Note: Subjects with controlled hypertension without cardiac compromise will be allowed to enroll. See exclusion criterion #18 for prohibited medications. 9. Neurological and neurodevelopmental disorders (including disorders of the brain, spinal cord, peripheral nerve, and muscle, eg, cerebral palsy, epilepsy [seizure disorders], stroke, muscular dystrophy, or spinal cord injury). Note: Minor neurological disorders (eg, past concussions, headaches, migraine) are allowed. 10. Malignant tumor or history of malignancy that may interfere with the aims of the study or a subject completing the study. 11. Prior receipt or the subject is waiting to receive a bone marrow, stem cell, or solid organ transplantation. 12. Diagnosis of cystic fibrosis. 13. Known positive human immunodeficiency virus, active hepatitis A virus infection, chronic hepatitis B virus infection, and/or current or treated hepatitis C virus infection. 14. Prior or planned ileal resection or bariatric surgery. Note: Subjects who have undergone gastric surgeries that do not affect drug absorption (eg, gastric band or gastric sleeve procedures) will be allowed to participate if they are stable for at least 1 year prior to Screening. Gastrectomy will be allowed if stable for at least 3 years prior to Screening. 15. Pregnant or nursing female subjects. 16. History of alcohol addiction or current heavy alcohol use defined as: >14 standard drinks per week and/or >=4 standard drinks per occasion for males and >7 standard drinks per week and/or >=3 standard drinks per occasion for females. A standard drink is 12 oz of beer (5% alcohol), 5 oz table wine (12% alcohol), or 1.5 oz of spirits (40% alcohol). 17. Known or suspected, in the opinion of the Investigator, renal disease or renal impairment. 18. Twelve-lead ECG demonstrating a QT interval corrected for heart rate according to Fridericia (QTcF) that is >500 msec or other clinically relevant abnormalities as judged by the Investigator at Screening. 19. Use of or intention to use excluded or c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint • Effect of EDP-938 compared to placebo on RSV infection clinical symptoms measured as the total symptom score (TSS) area under the curve (AUC) from Day 1 through Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints • The AUC for RSV RNA viral load measured in nasopharyngeal swab samples by quantitative reverse transcription polymerase chain reaction (RT-qPCR) • Percentage of subjects with RSV RNA viral load below the lower limit of quantitation in subjects receiving EDP-938 compared to placebo • Plasma PK concentrations of EDP-938 and its major metabolites (EP-024636, EP-024594, and EP-024595) • Safety endpoints include, but are not limited to, adverse events (AEs), vital sign measurements, pulse oximetry measurements, and clinical laboratory test results (including chemistry, hematology, and urinalysis) • Time to RSV RNA viral load below the lower limit of quantitation in subjects receiving EDP-938 compared to placebo • RSV RNA viral load change from Baseline Exploratory Endpoints • Resistance to EDP-938 in RSV obtained from nasopharyngeal swab samples • Correlation between EDP-938 plasma concentration and viral load and clinical symptoms • The FLU-PRO questionnaire evaluation across visits • RSV RNA viral load AUC and TSS AUC by RSV subgroup A or B | — |
Countries
Netherlands
Outcome results
None listed