Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Refractory Chronic Cough

Exclusion Criteria

• •Prior treatment with serlopitant or other NK1-R antagonist
• •Presence of any medical condition or disability that could interfere with study
• •History of hypersensitivity to serlopitant or any of its components
• •Currently pregnant or male partner of pregnant female
• •Females of childbearing potential who are unable or unwilling to use adequate contraception or who are breast feeding
• •Current smoker or individuals who have given up smoking within the past 12 months
• •FEV1/FVC \< 60%
• •Body mass index (BMI) \<18 kg/m2 or ≥ 40 kg/m2 at Screening
• •History of upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline Visit (Day 0)
• •History of cystic fibrosis
• •History of opioid use within 1 week of the Baseline Visit (Day 0)
• •Requiring concomitant therapy with prohibited medications
• •Treatment with biologic therapies within 8 weeks or 5 half-lives prior to the Baseline Visit (Day 0), whichever is longer
• •Treatment with strong CYP3A4 inhibitors within 4 weeks prior to the Baseline Visit (Day 0)
• •Treatment with any investigational therapy within 4 weeks (investigational biologic therapies within 8 weeks) prior to the Baseline Visit (Day 0)
• •Serum creatinine, total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2x the upper limit of normal (ULN) during screening
• •Positive test for any drug of abuse
• •History of malignancy within 5 years prior to the Baseline Visit (Day 0), with the exception of completely treated and non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin
• •Any known psychiatric diagnosis meeting DSM-5 criteria which may confound the assessment of serlopitant safety or efficacy, or interfere with the subject's ability to comply with protocol-mandated activities, within 3 years prior to randomization. Examples of such DSM-5 diagnoses include but are not limited to major depressive disorder, bipolar disorder, schizophrenia, psychotic disorder, intellectual disability, severe alcohol use disorder.
• •Known active hepatitis infection
• •Known history of human immunodeficiency virus (HIV) infection