An Investigation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2245035 in Healthy Volunteers and Allergic Rhinitics.

Exclusion Criteria

• •History of immunologic or haematologic deficiencies or diseases, except conditions that in the opinion of the Investigator and the GSK Medical Monitor are unlikely to introduce additional risk factors.
• •Current diagnosis of asthma.
• •Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforation, nasal polyps, other nasal malformations or history of frequent nosebleeds.
• •History of haematologic, gastro-intestinal, hepatic, renal or other condition that may influence the absorption, distribution, metabolism, excretion or action of the drug.
• •History of frequent headaches and/or migraine.
• •A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
• •A positive test for Human Immunodeficiency Virus antibody
• •A positive screening or pre-dose drug/alcohol screen, or a positive pre-dose smoking test
• •History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of greater than 21 units for males or greater than 14 units for females. One unit is equivalent to 8 grams (8g) of alcohol: a half-pint or approximately 240 millilitres (240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
• •The subject has participated in a clinical trial and has received an investigational product within 3 months prior to the first dosing day in the current study.
• •Exposure to more than four new chemical entities within 6 months prior to the first dosing day.
• •History of drug or other allergy that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates participation in this study.
• •Donation of blood or blood products in excess of 500 mL within a 90-day period.
• •History of sensitivity to heparin or heparin-induced thrombocytopenia
• •Unwillingness or inability to follow the procedures outlined in the protocol.
• •Subject is mentally or legally incapacitated
• •History of rhinitis, including allergic, non-allergic rhinitis and rhinosinusitis. Subjects with recent upper respiratory tract infections (URTIs) will be allowed in the study only if their nasal symptoms have been completely resolved for more than 3 weeks prior to screening.
• •Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to entry to the clinic, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
• •Subjects with recent upper respiratory tract infections (URTIs) will be allowed in the study only if their nasal symptoms have been completely resolved for more than 3 weeks prior to screening.
• •Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to entry into the clinic, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety. Subjects using treatment for allergies and AR may participate in the study if they remain free of medication for the following periods of time prior to entry into the clinic:
• •* Nasal antihistamines: 48 hours
• •* Oral antihistamines A (cetirizine, fexofenadine, loratadine, desloratadine): 72 hours
• •* Oral antihistamines B (all others): 72 hours
• •* Nasal decongestants: 24 hours
• •* Oral decongestants: 24 hours
• •* Nasal glucocorticosteroids: 4 weeks
• •* Oral glucocorticosteroids: 12 weeks
• •* Oral leukotriene receptor antagonists: 7 days