Presatovir in Lung Transplant (LT) Recipients With Respiratory Syncytial Virus (RSV) Infection
Condition: Respiratory Syncytial Virus (RSV)
MeSH terms: Infections; Virus Diseases
Intervention: Presatovir; Placebo
Intervention description: Tablets administered orally or via nasogastric (NG) tube once daily; Tablets administered orally or via NG tube once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Respiratory Syncytial Virus (RSV); Antiviral; Lung Transplant

Summary:

      The primary objective of this study is to evaluate the effect of presatovir on nasal
      respiratory syncytial virus (RSV) viral load in RSV-positive lung transplant (LT) recipients
      with acute respiratory symptoms.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Males and females ≥18 years of age who have received a LT (single or double) or
             heart/lung transplant > 90 days prior to Screening

          -  Confirmed to be RSV-positive by local polymerase chain reaction (PCR) testing
             (starting from when the upper or lower respiratory tract sample is obtained) ≤ 7 days
             prior to investigational medicinal product (IMP) administration on Day 1/Baseline

          -  New onset or acute worsening, if the symptom is chronic, of at least 1 of the
             following respiratory symptoms ≤ 7 days prior to IMP administration on Day 1/Baseline:
             nasal congestion, earache, runny nose, cough, sore throat, shortness of breath, or
             wheezing

          -  A negative local urine or serum pregnancy test for female subjects of childbearing
             potential at Screening, within 1 day prior to IMP administration. When available,
             existing local pregnancy test results obtained prior to Screening may be used,
             provided the testing was completed within 1 day prior to IMP administration

          -  Agreement from male and female subjects of childbearing potential who engage in
             heterosexual intercourse to use protocol specified method(s) of contraception

        Key Exclusion Criteria:

        Related to concomitant or previous medication use:

          -  Use of any non-marketed (according to region) investigational agents within 30 days,
             OR use of any investigational monoclonal anti-RSV antibodies within 4 months or 5
             half-lives of Screening, whichever is longer, OR use of any prior investigational RSV
             vaccines

          -  Use of a strong or moderate cytochrome P450 enzyme (CYP) inducer including but not
             limited to rifampin, St. John's Wort, carbamazepine, phenytoin, efavirenz, bosentan,
             etravirine, modafinil, and nafcillin, within 2 weeks prior to the first dose of IMP

        Related to transplant history:

        • Recipient of any other organ transplant prior to Screening, with the exception of a LT
        (single or double) or heart/lung transplant

        Related to medical condition at Screening:

          -  Known viral coinfection (including but not limited to influenza, metapneumovirus,
             human rhinovirus, parainfluenza, cytomegalovirus, or coronavirus) in the upper or
             lower respiratory tract ≤ 14 days prior to Screening unless discussed with the medical
             monitor and deemed acceptable

          -  Active systemic infection or infectious pneumonia of any etiology (ie, bacterial,
             viral [other than RSV] or fungal), including aspiration pneumonia, that is considered
             clinically significant by the investigator unless discussed with the medical monitor
             and deemed acceptable

        Related to laboratory values:

          -  Clinically significant kidney dysfunction as defined by: An estimated glomerular
             filtration rate (eGFR) < 30 mL/min/1.73 m2 as calculated by the Modification of Diet
             in Renal Disease (MDRD) study 4 parameter equation obtained from screening laboratory
             measurements or via local laboratory measurements obtained ≤ 7 days prior to
             Screening. The eGFR may be manually calculated or the reported eGFR value may be used,
             but any automatically calculated eGFR must be calculated using the MDRD equation.

          -  Clinically significant liver function test abnormalities as defined by an alanine
             aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit
             of normal (ULN) obtained in screening laboratory measurements or via local laboratory
             measurements obtained ≤ 7 days prior to Screening

          -  Clinically significant elevations in total bilirubin (TB), as determined by the
             investigator

        Note: Other protocol defined Inclusion/ Exclusion criteria may apply.