Eligibility determination
Item
Did the subject meet all entry criteria (i.e., all "YES" answers for inclusion criteria, all "NO" answers for exclusion criteria)?
boolean
C0013893 (UMLS CUI [1])
Healthy adult male aged between 18- 55 years
Item
Healthy adult male aged between 18 - 55 years
boolean
C3898900 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Body mass index (BMI)
Item
Body mass index (BMI) within the range 18.5–29.9 kg/m2
boolean
C1305855 (UMLS CUI [1])
Forced exspiratory volume in 1 second (FEV1) and FEV1/Forced Vital Capacity (FVC) ratio
Item
Forced expiratory volume in 1 second (FEV1) ≥80% predicted and a FEV1/Forced Vital Capacity (FVC) ratio ≥0.7
boolean
C0024109 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
C0849974 (UMLS CUI [1,3])
C0024109 (UMLS CUI [2,1])
C0024119 (UMLS CUI [2,2])
C0429745 (UMLS CUI [2,3])
Informed consent
Item
A signed and dated written informed consent was obtained from the subject
boolean
C0021430 (UMLS CUI [1])
Comprehension of and Corresponding to protocol requirements, instructions and protocol-stated restrictions
Item
The subject was able to understand and comply with the protocol requirements, instructions and protocol-stated restrictions
boolean
C2348563 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C2348563 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
tobacco use
Item
Subjects who were current non-smokers who had not used any tobacco products in the 6-month period preceding the screening visit and had a pack history of ≤10 pack years (pack history = (number of cigarettes per day/20) x number of years smoked).
boolean
C0543414 (UMLS CUI [1])
clinically relevant abnormality identified at the screening medical assessment
Item
Any clinically relevant abnormality identified at the screening medical assessment (physical examination/medical history), clinical laboratory tests, or ECG (12-lead or Holter)
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,3])
C1704258 (UMLS CUI [2,1])
C2985739 (UMLS CUI [2,2])
C0262926 (UMLS CUI [2,3])
C1704258 (UMLS CUI [3,1])
C2985739 (UMLS CUI [3,2])
C0022885 (UMLS CUI [3,3])
C1704258 (UMLS CUI [4,1])
C2985739 (UMLS CUI [4,2])
C1623258 (UMLS CUI [4,3])
History of breathing problems
Item
A history of breathing problems (eg history of asthmatic symptoms)
boolean
C0262926 (UMLS CUI [1,1])
C0035203 (UMLS CUI [1,2])
C1254481 (UMLS CUI [1,3])
Abnormal screening ECG
Item
A mean QTc(B) value at screening >430 msec, any of the 3 screening ECGs not within 10% of the mean, a mean PR interval outside the range 120 - 210 msec or an ECG that was not suitable for QT measurements (eg poorly defined termination of the T wave)
boolean
C1623258 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C0489625 (UMLS CUI [1,3])
C0444504 (UMLS CUI [1,4])
C1623258 (UMLS CUI [2,1])
C0220908 (UMLS CUI [2,2])
C0429087 (UMLS CUI [2,3])
C0444504 (UMLS CUI [2,4])
C1623258 (UMLS CUI [3,1])
C0220908 (UMLS CUI [3,2])
C0577807 (UMLS CUI [3,3])
C3827727 (UMLS CUI [3,4])
Supine blood pressure in medical history and at screening
Item
A history of elevated supine blood pressure (BP) or a mean supine BP equal to or higher than 150/90 millimetres of mercury (mm Hg) at screening
boolean
C0005823 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0005823 (UMLS CUI [2,1])
C0038846 (UMLS CUI [2,2])
C0220908 (UMLS CUI [2,3])
Mean heart rate at screening
Item
A mean heart rate (HR) outside the range 40 - 90 beats per minute (beats/min) at screening
boolean
C0018810 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,3])
Blood donation
Item
The subject had donated a unit of blood within the last 56 d or intended to donate within 56 d after completing the study
boolean
C0005794 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0005794 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Use of prescription or non-prescription drugs
Item
The subject had used prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John’s wort) within 7 d (or 14 d if the drug was a potential enzyme inducer) or 5 half-lives (which ever was longer) prior to the first dose of study medication, unless in the opinion of the Investigator and sponsor the medication would not interfere with the study procedures or compromise subject safety
boolean
C0304227 (UMLS CUI [1,1])
C0013231 (UMLS CUI [1,2])
C0332257 (UMLS CUI [1,3])
C0042890 (UMLS CUI [1,4])
C1504473 (UMLS CUI [1,5])
C0242295 (UMLS CUI [1,6])
Participation in a clinical study with a New Chemical Entity (NCE) or any other drug
Item
The subject had participated in a clinical study with a New Chemical Entity (NCE) within the past 112 d or any other drug within a clinical study during the previous 84 d
boolean
C2348568 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0220806 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,4])
C2348568 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0262926 (UMLS CUI [2,3])
Positive testing for hepatitis C antibody or hepatitis B surface antigen
Item
The subject had tested positive for hepatitis C antibody or hepatitis B surface antigen
boolean
C0281863 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
Positive pre-study urine drug or alcohol breath test screen
Item
The subject had a positive pre-study urine drug or alcohol breath test screen. A minimum list of drugs that were screened for included amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines
boolean
C0743300 (UMLS CUI [1])
C1112499 (UMLS CUI [2])
Alcohol consumption
Item
A history of regular alcohol consumption exceeding a weekly intake of 21 units, or an average daily intake of 3 units
boolean
C0001948 (UMLS CUI [1,1])
C0332174 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,4])
History of drug or other allergy
Item
The subject had a history of drug or other allergy, which, in the opinion of the responsible physician, contraindicated his participation
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C1301624 (UMLS CUI [1,4])
C0030699 (UMLS CUI [1,5])
C0020517 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0262926 (UMLS CUI [2,3])
C1301624 (UMLS CUI [2,4])
C0030699 (UMLS CUI [2,5])