Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Vyne Therapeutics Inc.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Female and males between 18 and 80 years of age
Have a diagnosis of treatment refractory chronic cough or unexplained cough for at least one year
Chest radiograph or computed tomography (CT) Thorax within the last 5 years not demonstrating any abnormality considered to be significantly contributing to the chronic cough
At Screening have a score of ≥ 40mm on the Cough Severity VAS
At Baseline (Day 0) have a score of ≥ 40mm on the Cough Severity VAS
All female subjects who are of childbearing potential must practice highly effective contraception (i.e., pregnancy prevention method with a failure rate of \< 1% per year) from the time of the initial screening visit until 4 weeks after last dose of study drug. Please refer to the protocol for acceptable methods of contraception
You may not be if
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
Clareo Health | Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Refractory Chronic Cough
