Acute cough in participants with induced viral upper respiratory tract infection MedDRA version: 20.1 Level: PT Classification code 10047482 Term: Viral upper respiratory tract infection System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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) OR 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
Exclusion criteria
Exclusion criteria: 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) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of MK-7264 on cough frequency as measured while awake during a 24-hour period;Secondary Objective: 1. To evaluate the efficacy of MK-7264 on the perception of cough severity 2. To evaluate the efficacy of MK-7264 on cough-specific quality of life 3. To evaluate the safety and tolerability of MK-7264;Primary end point(s): Awake coughs per hour on Day 3 of treatment.;Timepoint(s) of evaluation of this end point: Day 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Cough Severity VAS score measured as change from baseline on Day 3. CSD score measured as change from baseline on Day 3 LCQ-acute score measured as change from baseline on Day 3 Number of participants experiencing AEs. Number of participants discontinuing study treatment due to AEs;Timepoint(s) of evaluation of this end point: Day 3 (for efficacy) and throughout trial (for safety) | — |
Countries
United Kingdom
Outcome results
None listed