E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001723 |
E.1.2 | Term | Allergic rhinitis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
- 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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |