Mild Allergic Asthma MedDRA version: 9.1 Level: LLT Classification code 10001705 Term: Allergic asthma
Conditions
Interventions
Product Name: MEM 1414 tablets
Product Code: MEM 1414
Pharmaceutical Form: Film-coated tablet
CAS Number: 460080-73-3
Current Sponsor code: MEM 1414 or RO4577259
Concentration unit: mg milligram(s)
Co
Sponsors
Memory Pharmaceuticals Corp
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects between the ages of 18 and 55 years (inclusive). 2. Non- or ex-smokers who are expected to not smoke for the duration of the trial (an ex-smoker being defined as someone with =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any hospitalizations due to asthma in the past 3 years. 2. Treatment with the following medications: • Oral corticosteroids: More than once in the previous 12 months or within 8 weeks of screening • Inhaled or nasal corticosteroids in the previous 4 weeks before screening for this study • A leukotriene receptor antagonist (LTRA), 5-lipoxygenase inhibitor, theophylline or cromones (e.g. cromolyn, nedocromil) in the previous 2 weeks before screening for this study • Long-acting beta2-agonists (LABA) or anticholinergics in the previous 7 days before screening for this study • Short-acting antihistamines and tranquilizers in the previous 7 days before screening for this study • Long-acting antihistamines in the previous 2 weeks before screening for this study • Anti-IgE in the previous 6 months before screening for this study. • Previous treatment with immunotherapy • Vaccinations (e.g. anti-influenza) in the previous 3 months before screening for this study • Antidepressants within the previous 2 weeks before screening for this study. • ß-adrenoreceptor blocking agents within the previous 3 days before screening for this study. 3. Significant illness or disease other than asthma. 4. History of severe hypersensitivity or allergy to any drug. 5. Symptomatic allergic rhinitis (those with a history of allergic rhinitis may participate if asymptomatic at screening and, if in the opinion of the investigator, it is unlikely that disease exacerbation will occur during the course of the study). 6. Presence of any active respiratory tract infection, whether bacterial, viral, or fungal in origin within 3 weeks of screening. 7. Have unstable cardiovascular, gastrointestinal, hepatic, musculoskeletal, metabolic, endocrine, neurological or psychiatric disease or have had any clinically significant medical condition other than asthma within 1 month (30 days) prior to screening. 8. Have rheumatoid arthritis, a connective tissue disorder, or any other condition known to be associated with chronic inflammation (e.g. Inflammatory Bowel Disease). 9. Major surgery in the past 3 months before screening. 10. Have evidence of significant renal insufficiency, indicated by a serum creatinine greater than the upper limit of normal at screening. 11. Have either of the following liver test abnormalities at screening: • Aspartate transaminase (AST) or alanine transaminase (ALT) 1.5 times greater than the upper limit of normal • Total bilirubin greater than 1.2 times the upper limit of normal. 12. Have insulin-dependent diabetes mellitus or uncontrolled diabetes mellitus, as evidenced by HbA1C level greater than or equal to 8.0% at screening. 13. Have a history of malignancy other than in situ tumors. 14. Have a history of bone disease (e.g., osteoporosis, osteopenia) or suffered from a bone fracture in the previous 12 months before screening. 15. Have any of the following hematologic abnormalities at screening: • Hemoglobin 500 ml) or donated blood in the 30 days before screening. 19. Have participated in a clinical trial, where Investigational Product was received, in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of MEM 1414 compared to placebo on the late asthmatic response following an inhaled allergen challenge, as measured by changes in FEV1 compared to baseline. ;Secondary Objective: 1. To assess the efficacy of MEM 1414 compared to placebo on the late asthmatic response following an inhaled allergen challenge, as measured by • Changes in allergen-induced airway hyperresponsiveness (via pre- versus 24-hour post-allergen challenge PC20 methacholine values) • Changes in the following biomarkers of allergen-induced airway inflammation compared to baseline: Exhaled nitric oxide (eNO), Various chemical mediators of inflammation 2. To investigate the safety and tolerability of MEM 1414 compared to placebo in steroid-free subjects with mild allergic asthma. 3. To characterize the pharmacokinetic profile of MEM 1414 in steroid-free subjects with mild allergic asthma. ;Primary end point(s): Change in FEV1 | — |
Countries
United Kingdom
Outcome results
None listed