A randomised, double-blind, placebo-controlled, 2-period crossover study to evaluate effects of multiple oral doses of S-555739 on nasal allergen challenge in subjects with intermittent grass pollen sensitive allergic rhinitis.
- Conditions
- Allergic rhinitisMedDRA version: 9.1Level: LLTClassification code 10001723Term: Allergic rhinitis
- Registration Number
- EUCTR2008-006788-35-FR
- Lead Sponsor
- Shionogi & Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
Subjects must meet all of the following to be included in the study:
1) Those who understand the procedures of the study and agree to participate in the study by providing written informed consent.
2) Men and women between 18 and 55 years of age at screening. Women should be no longer of child bearing potential (should be surgically sterilised or should be post-menopausal confirmed by FSH dosage).
3) Those with body mass index (BMI) of =18.0 to <29 kg/m2
4) Current non-smokers from at least 6 months before the study initiation.
5) Those judged to be in generally good health and without any clinically significant findings on the basis of the medical history, physical and nasal examination, and laboratory evaluation.
6) Those who have positive responses to allergen-induced NAC at the screening visit.
7) Those with at least a documented history, (from the data collected at the screening visit), of seasonal allergic rhinitis during the grass season but are currently asymptomatic.
8) Those demonstrating a positive percutaneous allergen skin test response to grass pollens (timothy (Phleum pratense), orchard (Dactylis glomerata), ryegrass (lolium perenne), Kentucky blue grass (poa pratensis) and/or sweet vernal grass (anthoxanthum odoratum)).
9) Must be affiliated with, or a beneficiary of, a French social security system.
10) The Investigator must consult the Fichier des Volontaires pour la Recherche Biomédicale (the National Index of volunteers) to register each volunteer in the index and to ensure that the exclusion period is respected and that the maximum annual compensation is not exceeded.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Subjects who meet any of the following criteria must be excluded from the study:
1) Current or recent past abusers of alcohol (alcohol consumption > 40 grams/day), or those with a positive alcohol breath test at screening or current users or recent past abuser of illicit drugs (amphetamines, benzodiazepines, barbiturates, cannabis, cocaine, opiates).
2) Women of child bearing potential.
3) Those who have participated in a clinical trial involving an investigational or marketed drug within 3 months of screening.
4) Those in a situation or any condition which, in the opinion of the investigator, may interfere with optimal participation in the study.
5) Those not willing to discontinue grapefruit whole or juice consumption during the study.
6) Those male subjects not willing to use contraceptive barriers during the study.
7) Those with a documented evidence of perennial allergic rhinitis at screening.
8) Those with active allergic rhinitis within 3 weeks prior to randomisation.
9) Those receiving medications for allergic rhinitis and/or asthma within 3 weeks prior to randomisation.
10) Those with a history of exclusively seasonal allergic asthma
11) Those with a positive wheal for house dust mite with no history of perennial disease and that is not clinically associated with symptoms.
12) Those with a positive skin prick test for at least one of the tree pollens Alder, Hazel tree, Ash tree, and Cypressus ashei
13) Those with an upper respiratory tract infection (URI), sinusitis, infectious rhinitis, ocular infection, or history of any of these within 3 weeks prior to randomisation.
14) Those unable to perform the active anterior rhinomanometry procedure.
15) Those with a baseline total NAR >0.4 Pa/cm3/s.
16) Those who respond to an intranasal control solution provocation with a >30% increase in total NAR.
17) Those who do not show PD100 at a 100IR allergen dose at screening test
18) Those who have undergone major surgical (requiring general anaesthetic) procedures or procedures to the nasopharynx within 4 weeks of screening.
19) Those with a history of an anaphylactic allergic reaction related to food or administration of either a marketed or investigational drug.
20) Those currently using any prescription or non-prescription drugs on a regular basis or within 2 weeks prior to screening
21) Those who have a positive reaction to any of the following tests: HBs antigen, anti-HCV antibodies, anti-HIV1 antibodies, anti-HIV2 antibodies
22) Those who had used any of the following drugs within the specified period of time: parenteral corticosteroids within 90 days; oral corticosteroids within 30 days prior to randomisation
23) Those who have donated 400 mL of blood within 12 weeks before randomisation or 200 mL or more within 4 weeks before randomisation or of any amount from screening to first visit
24) Those who have received immunotherapy within 6 months of screening.
25) Subject being the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff directly involved in the conduct of the protocol.
26) Volunteers without health insurance
27) Volunteers unable to be contacted in case of emergency
28) The participants belonging to any of the following categories: incarcerated persons, patients in an emergency situation, in-patients with mental disorders.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method