Inclusion Criteria, please select all boxes corresponding to violations of any inclusion/exclusion criteria
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AST, ALT, alkaline phosphatase and billrubin <= 1.SxULN (isolated billrubln > 1.SxULN Is acceptable if bilirubin is fractionated and direct billrubin <35%). (1)
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Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. (2)
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Male or female between 18 and 65 years of age Inclusive, at the time of signing the Informed consent. (3)
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A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MIU/ml and estradlol < 40 pg/ml (<140 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 in Section 8. 1 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 will 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. Child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until completion of the follow-up visit. (4)
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Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 16 weeks after the last dose. (5)
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Body mass index (BMI) within the range 18.5·29.0 kg/m2(inclusive). (6)
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Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 16 weeks after the last dose. (5)
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Body mass index (BMI) within the range 18.5·29.0 kg/m2(inclusive). (6)
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Capable of giving written Informed consent, which Includes compliance with the requirements and restrictions listed in the consent form (7)
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Average QTcF < 450 msec. (8)
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No clinically significant abnormality on the Holter ECG at screening. The criteria for Holter ECG at screening are stated in Appendix 3. (9)
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Subjects who are current non·smokers, who have not used any tobacco products in the 12 month period preceding the screening visit and have a pack history of < = 5 pack years. Number of pack years= (number of cigarettes per day/20) x number of years smoked (10)
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Able to satisfactorily use the dry powder inhaler. (11)
10As a result of medical interview, physical examination or screening investigations, the principal invest igator or delegate physician deems the subject unsuitable for the study. Subj ects must not have a systolic blood pressure above 145 mmHg or a diastolic pressure above 85 mmHg. (1)
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The subject has any history of breathing problems in adult life (i.e. history of asthmatic symptomatology). Screening lung function tests (FEV1) will be performed to confirm normal lung function parameters( >= 85% predicted). (2)
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Subjects who have suffered a lower respiratory tract Infection within 4 weeks of the screening visit. (3)
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Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). (4)
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The subject has been treated for or diagnosed with depression within six months of screening or has a history of significant psychiatric Illness. (5)
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A positive test lo, HIV antibody. (6)
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A positive pre-study Hepatitis 6 surface antigen or positive Hepatitis C antibody result within 3 months of screening (7)
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History of heavy 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 g of alcohol: a half-pint (240 ml) of beer, 1 glass (125 ml) of wine or l (25 m l) measure of spirits. (8)
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History or regular use of tobacco- or nicotine-containing products within 12 months prior to screening . (9)
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Positive carbon monoxide (CO) or alcohol breath test at screening or on admission to the Unit. (10)
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A positive pre-study urine drug screen or when randomly tested during the study. (11)
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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: 3 months, 5 half-lives or twice the duration of the biological effect of the investigationa l product (whichever is longer). (12)
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Exposure to more than four new chemical entities within 12 months prior to the first dosing day. (13)
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Use of prescription or non -prescription drugs, including vitamins, herbal and dietary supplements (includ ing St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half· llves (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety. (14)
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The subject has taken systemic, oral or depot corticosteroids less than 12 weeks before the screening visit . (15)
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The subject has taken inhaled, intranasal or topical steroids less than 4 weeks before the screening visit . (16)
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History of sensitivity or adverse reaction to any or the study medications including immediate or delayed hypersensitivity to any betaagonist, sympathomlmetic drug, or any intranasal, Inhaled or systemic corticosteroid therapy; known or suspected sensitivity to the constituents of the new powder inhaler (i.e. lactose or magnesium stearate), or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates participation. (17)
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History or severe milk protein allergy. (18)
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Where participation in the study wou ld result in donation of blood or blood prod ucts in excess of 500 ml within 3 months of the start of the study. (19)
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Pregnant females as determined by positive serum hCG test at screen ing or by positive serum or urine hCG test prior to dosing. (20)
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Lactating females. (21)
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Unwillingness or inability to follow the procedures outlined in the protocol. (22)
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Subject is mentally or legally incapacitated. (23)
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Consumption or red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication. (24)
Abnormal, Clinically significant (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form If the abnormality meets the protocol definition for an AE) (3)