SB656933

AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.

Vital signs included heart rate, systolic and diastolic blood pressure and body temperature. Prior to vital signs all participants rested for at least five minutes in the seated, semi-supine, or supine position. The choice of position was kept constant for the duration of the study. Any results falling outside the normal range were repeated at the discretion of the Investigator. Potential clinical concern range for systolic blood pressure: \<85 and \>160 millimeter of mercury (mmHg), for diastolic: \<45 and \>100 mmHg and heart rate: \<40 and \>110 beats per minute. Number of participants with vital signs of potential clinical importance are presented.

Hematology parameters were reviewed prior to participants receiving first dose of study medication. The potential clinical concern range for hematology parameters were: Red blood cell (RBC) count (low: \< 3.72 \* 10\^12/Liters (L) and high: \> 6.313 \* 10\^12/L), lymphocytes (low: \< 0.8 gigacells/L), hematocrit (low: \> 0.075 ratio change from Baseline and high: \> 0.54 ratio), mean cell hemoglobin (MCH) (low: \< 23.8 picograms (pg) and high: \> 39.6 pg), mean cell volume (MCV) (low: \<73 femtoliters (FL) and high: \>110 FL), platelet count (low: \< 100 gigacells/L and high: \> 550 gigacells/L), white blood cell (WBC) count (low: \< 3 gigacells/L and high: \> 20 gigacells/L) and eosinophils (high: \> 1 gigacells/L). Only those parameters for which at least one value of potential clinical concern was reported are summarized. Number of participants with hematology abnormalities of potential clinical importance are presented.

The potential clinical concern range for clinical chemistry parameters were: glucose (low: \< 2.8 millimole \[mmol\]/L and high: \> 9.4 mmol/L), creatine kinase (high: \> 3 \* upper limit of normal units \[ULN\]/L), phosphorous, inorganic (low: \< 0.8 mmol/L and high: \> 1.6 mmol/L), total bilirubin (high: ≥ 1.5 \* ULN micromole \[μmol\]/L), uric acid (low: \< 41.636 μmol/L and high: \> 582.904 μmol/L), alkaline phosphatase (ALP) (high: ≥ 2 \* ULN international units \[IU/L\]/L), gamma glutamyl transpeptidase (GGT) (high: ≥ 110 IU/L), carbon dioxide content (low: \< 18 mmol/L and high: \> 32 mmol/L), direct bilirubin (high: \> 1.5 \* ULN μmol/L), potassium (low: \< 3.0 mmol/L and high: \> 5.5 mmol/L) and aspartate aminotransferase (AST) (high: ≥ 3\* ULN IU/L). Only those parameters for which at least one value of potential clinical concern was reported are summarized. Number of participants with clinical chemistry abnormalities of potential clinical importance.

Prior to ECG recordings, all participants rested for at least 5 minutes in the seated, semi-supine, or supine position. The choice of position was kept constant for the duration of the study. Participants avoided hot and cold food for at least 30 minutes prior to an ECG measurement. Any results falling outside normal range were repeated at the discretion of the Investigator. ECG Baseline values taken within 2.5 hours prior to first dose were calculated using the mean value of triplicate pre-dose readings. Triplicate readings were taken at least five minutes apart. Participants agreed to abstain from hot and cold drinks and food prior to an ECG measurement. ECG machine calculated heart rate and measured PR, QRS, QT, and QT corrected by Bazett's formula (QTcB), QT corrected by Fridericia's formula (QTcF) intervals. Number of participants with abnormal (not clinically significant \[NCS\] and clinically significant \[CS\]) electrocardiogram (ECG) findings are presented.

CF is one of the most common, lethal, autosomal recessive disease characterized by airway obstruction, bronchiectasis and infection, and exocrine pancreatic insufficiency. Number of participants with CF exacerbation are presented.