Status:
COMPLETED
A 5-way Treatment Period Trial of Single Doses of Intranasal GSK256066 in Patients With Rhinitis
Lead Sponsor:
GlaxoSmithKline
Conditions:
Rhinitis, Allergic, Seasonal
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
This current study is planned as a dedicated pharmacodynamic (effect of drug on the body) study to investigate the dose response in rhinitic subjects at doses where GSK256066 has been proven to work (...
Eligibility Criteria
Inclusion
- The subject is healthy.
- Body mass index less than 29.0 kg/m² , weight range of 55.0kg (females 50kg) to 95.0kg inclusive.
- They have a history of hayfever (repeated yearly episodes).
- They have a positive skin prick test for grass pollen at or within the 12 months preceding the screening visit.
- They have a positive radioallergosorbent test for grass pollen at or within the 12 months preceding the screening visit.
- non-smokers.
- They must have a baseline FEV1\>80% predicted and a baseline FEV1(maximum recorded value)/ forced vital capacity (FVC) (maximum recorded value)\>70%
- They are capable of giving informed consent
- They are available to complete all study measurements.
Exclusion
- Pregnant or nursing females.
- Women of childbearing potential who are unwilling or unable to use an appropriate method of contraception.
- The subject has structural nasal abnormalities or nasal polyposis.
- Any respiratory disease other than mild stable asthma that is controlled with occasional use of as-needed short-acting beta-agonists and associated with normal lung function.
- The subject has a history of drug or other allergy that may contraindicate participation.
- The subject has participated in a study with a new molecular entity during the previous 4 months or in any clinical study in the previous 3 months
- The subject is concurrently participating in another clinical study and is exposed to an investigational or a non-investigational drug or device.
- The subject has a screening QTc value \>450msec, PR interval outside the range 120 to 240msec or an ECG that is not suitable for QT measurements.In addition subjects will be excluded if they have a history of atrial and ventricular arrhythmia.
- The subject has a supine blood pressure that is persistently higher than 140/90 millimetres of mercury (mmHg) at screening.
- The subject has donated a unit of blood (450mL) within the previous 3 months or intends to donate within 3 months of completing the study.
- The subject is currently taking regular (or a course of) medication whether prescribed or not, including steroids, vitamins, and herbal remedies (e.g. St. John's Wort). Paracetamol (\<2g/day) and occasional as needed use of short-acting beta agonists is permitted.
- Past or present disease which may affect study. outcome
- The subject regularly, or on average, drinks more than 4 units of alcohol per day - where 1 unit = ½ pint of beer (284mL), or 1 glass of wine (125mL), or 1 measure of spirit (25mL).
- The subject is at risk of non-compliance with the study procedures/restrictions.
- The subject has Hepatitis B, Hepatitis C, or HIV virus.
Key Trial Info
Start Date :
March 28 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 16 2007
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00464568
Start Date
March 28 2007
End Date
May 16 2007
Last Update
August 20 2018
Active Locations (1)
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1
GSK Investigational Site
Berlin, Germany, 14050