Study of Gefapixant (MK-7264) in Adult Japanese Participants With Unexplained or Refractory Chronic Cough (MK-7264-033)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 2

Conditions

Chronic Cough

Treatments

Drug: Gefapixant 45 mg

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03482713

MK-7264-033 (Other Identifier)

183925 (Registry Identifier)

7264-033

Details and patient eligibility

About

This estimation study (no hypotheses) will evaluate the safety, tolerability, and efficacy of gefapixant (MK-7264) in Japanese adult participants with unexplained or refractory chronic cough.

Enrollment

23 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Chest radiograph or computed tomography scan of the thorax (within 5 years of Screening/Visit 1 and after the onset of chronic cough) not demonstrating any abnormality considered to be significantly contributing to the chronic cough or any other clinically significant lung disease in the opinion of the principal investigator or the sub-investigator.
Has had chronic cough for ≥ 1 year and a diagnosis of refractory chronic cough or unexplained chronic cough.
For female participants, is a female who is not pregnant, not breastfeeding, not of childbearing potential, or agrees to follow contraceptive guidance
Provides written informed consent and is willing and able to comply with the study protocol (including use of the digital cough recording device and completion of study questionnaires)

Exclusion criteria

Is a current smoker or has given up smoking within 12 months of Screening, or is a former smoker with a pack-year history >20 pack-years
Has a history of upper or lower respiratory tract infection or recent clinically significant change in pulmonary status
Has a history of chronic bronchitis
Is currently taking an angiotensin converting enzyme inhibitor (ACEI), or has used an ACEI within 3 months of Screening
Has a history of malignancy ≤5 years
Has a screening systolic blood pressure >160 millimeters of mercury (mmHg) or a diastolic blood pressure >90 mm Hg
Has a history of cutaneous adverse drug reaction to sulfonamides with or without systemic symptoms or history of anaphylaxis to sulfonamides
Is a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence
Has a known allergy/sensitivity or contraindication to gefapixant
Has donated or lost ≥1 unit of blood within 8 weeks prior to the first dose of gefapixant
Has previously received gefapixant or is currently participating in or has participated in an interventional clinical study