A study to learn how well the drug EDP 938 works and how safe it is in people who are able to walk around and are infected with Respiratory Syncytial Virus
- Conditions
- Respiratory syncytial virus (RSV)MedDRA version: 21.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2020-001529-30-NL
- Lead Sponsor
- Enanta Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 70
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 =40 kg/m2.
7. Negative urine pregnancy test for women of childbearing potential as defined in inclusion criterion #8.
8. A woman of childbearing potential who is sexually active with a male must agree to use two effective methods of contraception from the date of Screening until 30 days after her last dose of study drug. Effective methods of contraception are defined as:
A condom for the male partner and at least one of the following for the female subject:
a. Intrauterine device
b. Occlusive cap (diaphragm or cervical/vault caps)
c. Oral, injectable, implantable, transdermal, or intravaginal hormonal contraceptive
Note: The above does not apply to a female subject who has a vasectomized male as the sole partner or who is of nonchildbearing potential (ie, physiologically incapable of becoming pregnant) as defined below:
a. Has had a complete hysterectomy =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 Asthma (GINA) Step 2, 3, or 4 treatment, with stable dosing for at least 4 weeks prior to Screening.
13. Stable prebronchodilator forced expiratory volume in 1 second (FEV1) =60% of predicted within
1.Clinical evidence lower RTI determined by Investigator
2.Anticipated need for hospitalization,emerg. room care within 24 hours Screening
3.Receipt of systemic antiviral,antibacterial,antifungal, antimycobacterial therapy within 7days screening study duration
4. Concomitant respir. infec. that are viral (other than RSV),bacterial,fungal, including systemic bacterial,fungal infec.,within 7days Screening
5.Severe acute respir. syndrome coronavirus 2 (SARS-CoV-2) positive within 28days of Screening at Screening following signature of full ICF
6.Frailty scale score =4 at Screening
7.History chronic liver disease (eg:hemochromatosis,Wilson’s disease,alpha-1 antitrypsin deficiency, autoimmune hepatitis,nonalcoholic steatohepatitis,and/or alcoholic liver disease); history biliary disease (eg:primary sclerosing cholangitis, cholecystitis,choledocholithiasis), history of portal hypertension. Diagnosis hepatic steatosis (fatty liver) not exclusionary
8.Heart disease:congenital heart disease,acute/chronic heart failure,ischemic heart disease,congenital long QT syndrome,clinical manifestation resulting in QT interval prolongation. Subjects with controlled hypertension without cardiac compromise allowed enroll. See exclusion criterion #18 for prohibited medications
9.Neurological,neurodevelopmental disorders (including disorders of brain,spinal cord,peripheral nerve,muscle,eg:cerebral palsy,epilepsy[seizure disorders] stroke, muscular dystrophy,spinal cord injury). Note:Minor neurological disorders (eg:past concussions,headaches,migraine) are allowed
10.Malignant tumor,history of malignancy that may interfere with aims of study or subject completing the study
11.Prior receipt or the subject is waiting to receive a bone marrow,stem cell,solid organ transplantation
12.Diagnosis 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,planned ileal resection or bariatric surgery. Note:Subjects who have undergone gastric surgeries don’t affect drug absorption (eg:gastric band/gastric sleeve procedures) will be allowed participate if stable for least 1 yr prior to Screening. Gastrectomy allowed if stable at least 3 years prior to Screening
15.Pregnant,nursing female subjects
16.History alcohol addiction/current heavy alcohol use def. >14 standard drinks per week and/or =4 standard drinks per occasion for males, >7 standard drinks per week and/or =3 standard drinks per occasion for females. A standard drink 12oz of beer (5%alcohol), 5oz table wine (12%alcohol)or 1.5oz of spirits (40%alcohol)
17.Known/suspected,in opinion of Investigator,renal disease or renal impairment
18.Twelve-lead ECG demonstrating QT interval corrected for heart rate according to Fridericia (QTcF) that is >500 msec or other clinically relevant abnormalities as judged by Investigator at Screening
19.Use or intention to use excluded or contraindicated medication(s),supplements, including medication known to be moderate,potent inducer,inhibitor of CYP3A4 enzyme,within 14 days prior Screening for the duration of study
20.Receipt of =14 days systemic immunomodulator therapy (eg,oral corticosteroids) within 3months of Screening
21.Prior first dose study drug-during study participation,subject received any vaccine,investigational agent,or biological product within 30days or 5x the 1/2life, whichever longer. Note:Influenza vaccination within 7days S
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method