Clinical trial NCT03372603 (phase 1/phase 2, status: terminated)
Conditions: cough
ICD codes: R05.1, R05.2, R05.3, R05.4, R05.9, G44.83, J45.991
Drugs: gsk2798745, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    study terminated due to lack of efficacy of gsk2798745 in chronic cough.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Age between 18 and 75 years of age inclusive, at the time of signing the informed
             consent.

          -  Chronic idiopathic cough for >=1 year (before screening), defined as: a cough that is
             unresponsive to at least 8 weeks of targeted treatment, or a cough for which no
             objective evidence of an underlying trigger has been determined, despite medical
             investigations.

          -  No significant findings on chest imaging (chest X-ray [CXR] or Computed tomography
             scan) within 12 months before screening (subjects with an abnormal CXR within 12
             months, from a temporary process, will be allowed to participate if a repeat CXR is
             normal).

          -  Forced expiratory volume in one second (FEV1) >=80% of the predicted normal value (at
             screening), or documented evidence of FEV1 >=80% within the 6 months before screening.

          -  Score of >=40 millimeters (mm) on the Cough Severity Visual Analogue Scale (VAS) at
             Screening.

          -  Body weight >=50 kilogram (kg) and body mass index (BMI) within the range 18 to 40
             kilogram per meter square (kg/m^2) (inclusive) at screening.

          -  A male participant must agree to follow the contraception requirements stated in the
             protocol from the time of first dose of study treatment until 2 weeks after last dose
             of study treatment, and refrain from donating sperm during this period.

          -  A female participant is eligible to participate if she is not of childbearing
             potential.

          -  Capable of giving signed informed consent, which includes compliance with the
             requirements and restrictions listed in the informed consent form (ICF) and in this
             protocol.

        Exclusion Criteria:

          -  History or current evidence of any serious or clinically significant gastrointestinal,
             renal, endocrine, neurologic, hematologic or other condition that is uncontrolled on
             permitted therapies or that would, in the opinion of the investigator or the medical
             monitor, make the subject unsuitable for inclusion in this study.

          -  History or current evidence of chronic productive cough.

          -  History of acute coronary syndromes (including unstable angina), coronary angioplasty,
             or stenting within the 6 months before screening.

          -  Active ulcer disease or gastrointestinal bleeding at the time of screening (positive
             fecal occult blood test [FOBT] at screening).

          -  History of stroke or seizure disorder within 5 years of screening.

          -  Respiratory tract infection within 6 weeks of screening.

          -  Subject who, in the investigator's opinion, poses a significant suicide risk. Evidence
             of serious suicide risk may include any history of suicidal behavior and/or any
             evidence of suicidal ideation on any questionnaires e.g. Type 4 or 5 on the Columbia
             Suicidality Severity Rating Scale (C-SSRS) in the last 6 months (assessed at
             screening).

          -  Alanine transferase (ALT) > twice the upper limit of normal (ULN) at screening.

          -  Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin
             is fractionated and direct bilirubin <35%) at screening.

          -  Current or chronic history of liver disease, or known hepatic or biliary abnormalities
             (with the exception of Gilbert's syndrome or asymptomatic gallstones).

          -  QT interval corrected (QTc) >450 milliseconds (msec) or QTc >480 msec in subjects with
             bundle branch block at screening.

          -  Use of a listed prohibited medication within the restricted timeframe relative to the
             first dose of study treatment.

          -  Use of a strong inhibitors or inducers of cytochrome P450 (CYP) 3A or pglycoprotein.

          -  Participation in the study would result in loss of blood or blood products in excess
             of 500 milliliters (mL) within 3 months of screening.

          -  Exposure to more than 4 new chemical entities within 12 months prior to the first
             dosing day.

          -  Current enrollment or past participation within the 3 months before screening in any
             clinical study involving an investigational study treatment or any other type of
             medical research.

          -  Positive human immunodeficiency virus (HIV) antibody test at screening.

          -  Presence of Hepatitis B surface antigen (HBsAg) at screening.

          -  Positive Hepatitis C antibody test result at screening or within 3 months prior to
             starting study treatment.

          -  Positive Hepatitis C ribonucleic acid (RNA) test result at screening or within 3
             months prior to first dose of study treatment.

          -  Cardiac troponin at screening > ULN for the assay.

          -  History of alcohol abuse within 6 months of screening, in the opinion of the
             investigator.

          -  Current smoker or history of smoking within the 6 months before screening, or a
             cumulative history of >= 20 pack years. Pack years = (Number of cigarettes
             smoked/day/20) x (Number of years smoked)

          -  Sensitivity to any of the study treatments, or components thereof, or drug or other
             allergy that, in the opinion of the investigator or Medical Monitor, contraindicates
             participation in the study.