EUCTR2017-003250-16-GB进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy, Safety, And Tolerability Of Serlopitant For The Treatment Of Refractory Chronic Cough
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 170
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Females and males between 18 and 80 years of age inclusive, at Screening
- •2. Chest radiograph or CT Thorax within the last 5 years not demonstrating any abnormality considered to be significantly contributing to the chronic cough in the opinion of the Principal Investigator and/or Menlo Therapeutics Medical Monitor
- •3. Have a diagnosis of treatment refractory chronic cough or unexplained cough for at least one year
- •4. At Screening have a score of = 40mm on the Cough Severity VAS
- •5. At Baseline (Day 0) have a score of = 40mm on the Cough Severity VAS
- •6. 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.
- •7. Have provided written informed consent
- •8. Are willing and able to comply with all aspects of the protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •1. Prior treatment with serlopitant or other neurokinin-1 receptor (NK1-R) antagonists (e.g., aprepitant, orvepitant)
- •2. Current smoker or individuals who have given up smoking within the past 12 months
- •3. FEV1/FVC < 60%
- •4. Body mass index (BMI) < 18 kg/m2 or = 40 kg/m2 at Screening
- •5. History of upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline Visit (Day 0)
- •6. History of cystic fibrosis
- •7. History of opioid use (for chronic cough) within 1 week of the Baseline Visit (Day 0)
- •8. Requiring concomitant therapy with prohibited medications
- •9. Treatment with biologic therapies within 8 weeks or 5 half-lives prior to the Baseline Visit (Day 0), whichever is longer
- •10. Treatment with strong CYP3A4 inhibitors within 4 weeks prior to the Baseline Visit (Day 0)
- •11. Treatment with any investigational therapy within 4 weeks (investigational biologic therapies within 8 weeks) prior to the Baseline Visit (Day 0)
- •12. Serum creatinine, total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2x the upper limit of normal (ULN) during screening
- •13. Positive test for any drug of abuse (certain drugs of abuse are acceptable for non-cough indications)
- •14. 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
- •15. 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
- •16. Known active hepatitis infection
- •17. Known history of human immunodeficiency virus (HIV) infection
- •18. History of hypersensitivity to serlopitant or any of its components
- •19. Currently pregnant or breastfeeding female subject
- •20. Females of childbearing potential who are unable or unwilling to practice highly effective contraception (pregnancy prevention)
- •21. Presence of any medical condition or disability that, in the investigator’s or Menlo Therapeutics Medical Monitor’s opinion, could interfere with the assessment of safety or efficacy in this trial or compromise the safety of the subject, including clinically significant ECG abnormalities during screening
- •22. Planned or anticipated major surgical procedure or other activity that would interfere with the subject’s ability to comply with protocol-mandated assessments (e.g., extended international travel) during the subject’s participation in the study.
研究者
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