Last updated: 11/04/2018 08:26:04

A 5-way treatment period trial of single doses of intranasal GSK256066 in patients with rhinitis

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GSK study ID
IPR109764
See study documents
Clinicaltrials.gov ID
NCT00464568
See results summary
EudraCT ID
2006-006710-15
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2007-16-05
    Observational study model:
    Not applicable
    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)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 14050
    Status
    Will Be Recruiting
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    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
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