Last updated: 11/04/2018 08:26:04
A 5-way treatment period trial of single doses of intranasal GSK256066 in patients with rhinitis
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A randomised, open, placebo-controlled 5-way crossover trial of single doses of intranasal GSK256066 in subjects with seasonal allergic rhinitis (SAR).
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Mean Messenger Ribonucleic Acid (mRNA) concentrations as a measure of gene expression
Timeframe: Day 1
Secondary outcomes:
Mean Forced expiratory volume in one second (FEV1)
Timeframe: Up to 9 weeks
Mean diastolic blood pressure (DBP) and systolic blood pressure (SBP) over study period
Timeframe: Up to 9 weeks
Mean heart rate over study period
Timeframe: Up to 9 weeks
Change from Baseline in electrocardiogram (ECG) values
Timeframe: Baseline (Day 1) to 9 weeks
Number of participants with adverse events (AE) and serious adverse events (SAE)
Timeframe: Up to 9 weeks
Number of participants with hematology values of potential clinical concern
Timeframe: Up to 9 weeks
Number of participants with clinical chemistry values of potential clinical concern
Timeframe: Up to 9 weeks
Area under the plasma drug concentration versus time curve (AUC0-last) of GSK256066
Timeframe: Pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1
AUC (0-last) of active metabolite GSK614917
Timeframe: Pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1
Maximum observed plasma drug concentration (Cmax) of GSK256066
Timeframe: Pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1
Cmax of active metabolite GSK614917
Timeframe: Pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1
Time to maximum observed plasma drug concentration (Tmax) and time to last observed plasma drug concentration (Tlast) of GSK256066
Timeframe: Pre -dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1
Tmax and Tlast of active metabolite GSK614917
Timeframe: Pre-dose, 15 minutes, 30 minutes, 1, 2, 3 and 4 hours post-dose on Day 1
Nasal lavage concentrations of GSK256066
Timeframe: Day 1
Mean levels of total vasodilator stimulated phosphoprotein (VASP) protein, phosphorylated(phospho)157 VASP (pVASP) and phospho239 VASP in lavage cells
Timeframe: Day 1
Interventions:
Drug: GSK256066
Enrollment:
32
Observational study model:
Not applicable
Primary completion date:
2007-16-05
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Rhinitis, Allergic, Seasonal
Product
GSK256066
Collaborators
Not applicable
Study date(s)
March 2007 to May 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 50 years
Accepts healthy volunteers
No
- The subject is healthy.
- Body mass index less than 29.0 kg/m² , weight range of 55.0kg (females 50kg) to 95.0kg inclusive.
- Pregnant or nursing females.
- Women of childbearing potential who are unwilling or unable to use an appropriate method of contraception.
Inclusion and exclusion criteria
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.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-16-05
Actual study completion date
2007-16-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website