A Study to Assess the Safety, Effects and Palatability of Sisunatovir in Healthy Adult Participants
Condition: Respiratory Syncytial Viruses
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is seeking healthy participants who are:

        1. Aged 18 to 65 years of age. All fertile participants must agree to use a highly
           effective method of contraception.

        2. Male and female participants who are overtly healthy as determined by medical
           evaluation. This includes medical history, physical examination, blood pressure, pulse
           rate, standard 12-lead ECG (electrocardiogram), and laboratory tests.

        3. BMI (body mass index) of 17.5 to 35 kg/m2; and a total body weight >50 kg (110 lb).

      This study will consist of up to 2 cohorts (groups of participants).:

      Cohort 1 is a randomized, 2-part, crossover cohort. Part 1 has 3 periods. Periods 1 and 2 are
      to evaluate the safety and effects of sisunatovir. Participants will take sisunatovir tablets
      or placebo by mouth once every 12 hours. A placebo looks like the study medicine but does not
      contain any active medicine in it.

      Period 3 is an open label period to evaluate the food effect of the planned higher dose of
      sisunatovir. Participants will take the planned higher dose sisunatovir tablets every 12
      hours. In Part 2, participants will take sisunatovir prepared in 4 different vehicles (water,
      infant formula, apple juice, and saline) to assess how palatable each form is. Participants
      will complete a questionnaire after tasting each form of sisunatovir. The palatability
      questionnaire will be completed for each vehicle, the questionnaire asks participants to
      assess each vehicle at 4 different time increments after tasting. At least 60 minutes will
      pass between tasting each vehicle. Period 4 may start after the last PK draw of Period 3.

      A minimum 7-day washout period will occur between the last dose of Periods 1 and 2 and the
      first dose of Periods 2 and 3. We will assess the safety of participants following each study
      period and doses and adjust the doses for subsequent study periods as needed.

      Cohort 2 is an optional cohort; the design of Cohort 2 is the same as Part 1 of Cohort 1.
      Dose levels studied in Cohort 2 will be determined after the completion of Cohort 1.

      Participants will take part in this study for approximately 2 months, excluding the screening
      period. During this time there are 3 separate 7-day in-patient stays at the study clinic and
      a follow-up phone call that takes place 28-35 days after the last dose of study medicine.
    


Intervention name(s): sisunatovir; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sisunatovir is an orally administered RSV F-protein inhibitor being developed to target viral-host cell fusion for the treatment of adult and pediatric patients with RSV; Placebo for sisunatovir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: RSV; respiratory syncytial virus