A 5-way Treatment Period Trial of Single Doses of Intranasal GSK256066 in Patients With Rhinitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00464568
First received: April 20, 2007
Last updated: May 31, 2012
Last verified: February 2011

April 20, 2007
May 31, 2012
March 2007
Not Provided
Effects of GSK256066 on ribonucleic acid (RNA) levels, which show phosphodiesterase-4 (PDE4) inhibition in nasal scrape samples and on protein biomarkers of PDE4 inhibition in lavage samples
Same as current
Complete list of historical versions of study NCT00464568 on ClinicalTrials.gov Archive Site
To explore the safety, tolerability and pharmacokinetics of single doses of GSK256066 in mild to moderate allergic rhinitic subjects. To explore the effects of GSK256066 on additional markers of PDE4 inhibition in nasal lavage.
Same as current
Not Provided
Not Provided
 
A 5-way Treatment Period Trial of Single Doses of Intranasal GSK256066 in Patients With Rhinitis
A Randomised, Open, Placebo-controlled 5-way Crossover Trial of Single Doses of Intranasal GSK256066 in Subjects With Seasonal Allergic Rhinitis (SAR).

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 (200mcg) or expected to (50mcg) work. This study also aims to investigate the lower end of the predicted therapeutic range.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
  • Rhinitis, Allergic, Seasonal
  • Seasonal Allergic Rhinitis
  • SAR
Drug: GSK256066
Other Name: GSK256066
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
May 2007
Not Provided

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00464568
IPR109764
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP