EUCTR2017-000472-28-GB进行中（未招募）1 期
A Phase 2a, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of MK-7264 on Acute Cough in Participants with Induced Viral Upper Respiratory Tract Infection - MK-7264 on cough with induced viral upper respiratory tract infection
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 46
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
- 性别
- All
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •1. In good general health with no clinically relevant abnormalities based on the medical history, physical examination, vital sign measurements, clinical laboratory evaluations (ie, hematology, clinical chemistry, and urinalysis), and 12-lead ECG.
- •2. Susceptible to HRV-16, as evidenced by a serum-neutralizing antibody titer of 1:4 or less, or the definition used by the individual clinic.
- •3. Between 18 and 55 years of age (inclusive) at the Screening Visit, of either gender, and of any race.
- •4. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- •a) Not a woman of childbearing potential (WOCBP)
- •b) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 14 days after the last dose of study treatment.
- •5. The participant (or legally acceptable representative, if applicable) provides written informed consent for the study. The participant may also provide consent for Future Biomedical Research. However the participant may participate in the study without participating in Future Biomedical Research.
- •6. Demonstrates an ability to follow study procedures (including use of the digital cough recording device [VitaloJAK™] and completing the PROs [Cough Severity VAS, CSD, LCQ-acute, and WURSS-24]) to the satisfaction of the investigator/qualified designee prior to randomization.
- •7. Has clinical laboratory tests (complete blood count [CBC], blood chemistries, including urine pregnancy for female participants of childbearing potential [ie, who have started menstruating], and urinalysis) conducted during Screening documented to be clinically acceptable to the investigator before beginning the Treatment Period. A female participant of childbearing potential (ie, who has started menstruating) must have a negative urine pregnancy test (or a negative serum pregnancy test, if required) at both the Screening Visit and Baseline Visit (Day -1) to be considered eligible for the trial.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 188
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •1. Donated blood within 56 days or donated plasma within 7 days prior to dosing.
- •2. Has forced expiratory volume in one second (FEV1) <70% of predicted and/or FEV1/forced vital capacity (FVC) ratio <80%.
- •3. Has a history of significant multiple and/or severe allergies (eg, food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability ( ie, systemic allergic reaction) to prescription or nonprescription drugs or food.
- •4. Has recent history of an upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline Visit (Day -1).
- •5. Has estimated glomerular filtration rate (eGFR) <50 mL/min/1.73 m2 (using the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) formula at Screening.
- •6. Has a history of cancer (malignancy).
- •7. Has any condition possibly affecting drug absorption (eg, gastrectomy, gastroplasty, any type of bariatric surgery, or vagotomy).
- •8. Has screening systolic blood pressure (SBP) >160 mm Hg or a diastolic blood pressure >90 mm Hg.
- •9. Has a body mass index <18 kg/m2 or =40 kg/m2.
- •10. Had major surgery or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to Screening.
- •11. Has history of a cutaneous adverse drug reaction to sulfonamides or signs and symptoms suggestive of anaphylaxis to sulfonamides.
- •12. Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases that might expose the participant to risk by participating in the trial or investigational product administration or confound the results of the trial, or interfere with the participant’s participation for the full duration of the trial, and, in the judgment of the investigator or Sponsor, would make the participant inappropriate for entry into this trial.
- •13. Is mentally or legally incapacitated, has significant emotional problems at the time of Screening, or is expected to during the conduct of the trial, or has a history of a clinically significant psychiatric disorder in the last 5 years. Participants who have had situational depression may be enrolled in the trial at the discretion of the investigator.
- •14. A WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of study treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- •15. Has received medications to treat an acute viral URTI within 24 hours of study enrollment (defined as Day -1) (including dextromethorphan, diphenhydramine, and narcotic analgesics).
- •16. Has received medications within 14 days prior to randomization or needs to continue to receive any treatment (prescription or OTC) during the current trial, including antacids, high-dose multivitamins, nutritional supplements, and herbal preparations, beginning approximately 2 weeks (or 5 half-lives of the prior/concomitant medication) prior to administration of the initial dose of study treatment, throughout the trial, until the post-treatment visit (Day 8).
- •17. Has previously received MK-7264.
- •18. Has participated in another investigational trial within 4 weeks (or 5 half-lives of the investigational product used in the other trial), whichever is greater, prior to the screening visit (the w
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