A randomized, double blind, placebo-controlled, 2-period cross over study to evaluate effects of S-555739 on prostaglandin D2 (PGD2) induced nasal airway resistance in healthy adult volunteers

• Conditions: Allergic rhinitis; MedDRA version: 9.1Level: LLTClassification code 10001723Term: Allergic rhinitis

• Registration Number: EUCTR2008-006787-11-GB
• Lead Sponsor: Shionogi & Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

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 <29 kg/m2.
4. Those judged to be in generally good health and with no clinically significant findings on the basis of the medical history, physical examination and laboratory evaluation.
5. Those who have positive responses to PGD2 induced NAR (PD75 =32 µg) at the screening visit.
6. Provide written (signed) informed consent to participate in the trial prior to any trial specific screening procedures, with the understanding that the subject has the right to withdraw from the trial at any time, without prejudice.

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified