Allergic rhinitis MedDRA version: 9.1 Level: LLT Classification code 10001723 Term: Allergic rhinitis
Conditions
Sponsors
Shionogi & Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria 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. Male between 18 and 55 years of age at screening. 3. Those with a body mass index (BMI) of =18.0 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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. Smokers within 6 months before the study. 3. Those who have participated in a clinical trial involving an investigational or marketed drug within 4 weeks 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 with active allergic rhinitis within 3 weeks prior to randomisation. 7. Those with perennial allergic rhinitis history who present current symptoms or within 3 weeks prior to randomisation. 8. Those receiving medications for allergic rhinitis and/or asthma within 3 weeks prior randomisation.. 9. Those with an upper respiratory tract infection (URI), sinusitis, infectious rhinitis, ocular infection, or history of any of these within 3 weeks prior to the randomisation. 10. Those unable to tolerate the active posterior rhinomanometry and / or acoustic rhinometry procedures. 11. Those with a baseline total NAR >0.4 Pa/cm3/s. 12. Those who respond to intranasal control solution provocation with a >30% increase in total NAR. 13. Those who have undergone major surgical (requiring general anaesthetic) procedures or procedures to the nasopharynx within 4 weeks of randomisation. 14. Those with a history of an anaphylactic allergic reaction related to food or administration of either a marketed or investigational drug. 15. Those currently using any prescription or non-prescription drugs on a regular basis or within 2 weeks prior to randomisation. 16. Those who have received immunotherapy within 6 months of randomisation. 17. Those who have donated 400 mL of blood within 12 weeks before randomisation or 200 mL or more, within the 4 weeks before randomisation or any amount from screening to first visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effects of multiple oral doses of S-555739 once daily on prostaglandin D2 (PGD2) induced total nasal airway resistance (NAR) in healthy adult subjects.;Secondary Objective: - To evaluate the effects of a single oral dose of S-555739 (100mg) on prostaglandin D2 (PGD2) induced total nasal airway resistance (NAR). - To evaluate the effects of S-555739 on the changes in nasal cross sectional area and volume following challenge with a range of doses of PGD2. - To measure the effects of S-555739 on the nasal symptoms resulting from challenge with PGD2, including rhinorrhea, nasal congestion, sneezing and pruritis. - To evaluate the general safety and tolerability of multiple oral doses of S-555739 100 mg once daily. ;Primary end point(s): The primary endpoint is the proportion of subjects with a higher PD75 on Day 8 of the S-555739 period than at Day 8 of the placebo period. PD75 is a dose of PGD2 required to induce a 75% increase in total NAR by the PGD2 challenge agent. | — |
Countries
United Kingdom
Outcome results
None listed