Clinical trial NCT02058407 (phase 1, status: terminated)
Conditions: bronchiectasis
ICD codes: J47.9, Q33.4, J47.1, J47.0
Drugs: gsk2793660 solution, gsk2793660 capsule, placebo solution, placebo capsule
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CC1=CC(O)=CC(C)=C1Cl
Reason stopped: 
    drug related aes observed upon repeat dosing that with longer treatment duration could become
    worse. required action on some biomarkers not observed.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Healthy as determined by a responsible and experienced physician, based on a medical
             evaluation including medical history, physical examination, and laboratory tests. A
             subject with a clinical abnormality or laboratory parameters outside the reference
             range, and which is not a part of an eligibility criterion, for the population being
             studied may be included only if the Investigator and GSK medical monitor consider the
             finding is unlikely to introduce additional risk factors and will not interfere with
             the study procedures and outcome.

          -  Male or female between 18 and 55 years of age inclusive, at the time of signing the
             informed consent.

          -  A female subject is eligible to participate if she is of: Non-childbearing potential
             defined as pre-menopausal females with a documented tubal ligation, removal of both
             ovaries or hysterectomy; or postmenopausal defined as 12 months of spontaneous
             amenorrhea [in questionable cases a blood sample with simultaneous follicle
             stimulating hormone (FSH) >21.7 International units per liter (IU/L) and oestradiol
             <110 picomole per liter (pmol/L) is confirmatory]. Females on hormone replacement
             therapy (HRT) and whose menopausal status is in doubt will be required to use one of
             the contraception methods listed in the protocol if they wish to continue their HRT
             during the study. Otherwise, they must discontinue HRT to allow confirmation of
             post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4
             weeks should elapse between the cessation of therapy and the blood draw; this interval
             depends on the type and dosage of HRT. Following confirmation of their post-menopausal
             status, they can resume use of HRT during the study without use of a contraceptive
             method.

          -  Male subjects with female partners of child-bearing potential must agree to use one of
             the approved contraception methods as detailed in the protocol. This criterion must be
             followed from the time of the first dose of study medication until the follow-up
             visit.

          -  Body weight >=50 Kilogram (kg) and Body Mass Index (BMI) within the range 19.9-30.0
             kg/meter square (m^2) (inclusive).

          -  Capable of giving written informed consent, which includes compliance with the
             requirements and restrictions listed in the consent form.

          -  Based on averaged QT duration corrected for heart rate by Fridericia's formula (QTcF)
             values of triplicate ECGs obtained over a brief recording period: Average QTcF <450
             milliseconds (msec)

          -  Systolic blood pressure <=130 millimeters of mercury (mmHg) and diastolic blood
             pressure 80 mmHg based on average values of triplicate blood pressure readings
             obtained over a brief period.

          -  Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin <=1.5x Upper Limit
             of Normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is
             fractionated and direct bilirubin <35%).

        Exclusion Criteria:

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

          -  ECG finding of second or third degree heart block.

          -  History of regular alcohol consumption within 6 months of the study defined as: an
             average weekly intake of >21 units for males or >14 units for females. One unit is
             equivalent to 8 gram of alcohol: a half-pint (approximately 240 milliliter [mL]) of
             beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.

          -  History of sensitivity to any of the study medications, or components thereof or a
             history of drug or other allergy that, in the opinion of the investigator or GSK
             Medical Monitor, contraindicates their participation.

          -  History of sensitivity to heparin or heparin-induced thrombocytopenia.

          -  A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody
             result within 3 months of screening.

          -  Urinary cotinine or exhaled breath carbon monoxide (CO) levels indicative of current
             smoking or history or regular use of tobacco- or nicotine-containing products within 6
             months prior to screening.

          -  A positive pre-study drug/alcohol screen.

          -  A positive test for human immunodeficiency virus (HIV) antibody.

          -  Where participation in the study would result in donation of blood or blood products
             in excess of 500 mL within a 56 day period. Blood donation will not exceed 500 mL for
             the entire study.

          -  The subject has participated in a clinical trial and has received an investigational
             product within the following time period prior to the first dosing day in the current
             study: 30 days, 5 half-lives or twice the duration of the biological effect of the
             investigational product (whichever is longer).

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