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

• Status: Completed
• Trial end date: 2018-09-06
• Target enrollment: 0
• Participant gender: All

Summary

Study of the efficacy, safety, and tolerability of serlopitant for the treatment of refractory chronic cough

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Menlo Therapeutics Inc.; Vyne Therapeutics Inc.
• Treatments: Serlopitant

Criteria

Inclusion Criteria:

• 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

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