Healthy volunteers. Study is primarily relevant in asthma and allergic rhinitis. Signs and Symptoms asthma and allergic rhinitis
Conditions
Interventions
AM103 orally or placebo
Single doses: 50, 150, 300, 600, 1000 mg
Multiple doses: Administered once daily for 11 days. The doses are: 150, 300 and 600 mg, with an additi
Sponsors
Amira Pharmaceuticals (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female between 18 and 65 years of age (for Multiple Dose Phase, male only) 2. Female subjects must be postmenopausal, surgically sterile, or be prepared to use two methods of contraceptives during the study and for 14 days after the end of dosing 3. Non-smoker 4. Good general health as determined by medical history, and by results of physical examination, vital signs, Electrocardiogram (ECG), and clinical laboratory tests obtained within 21 days (3 weeks) prior to study drug administration 5. Able to provide written informed consent and understand and comply with the requirements of the study
Exclusion criteria
Exclusion criteria: 1. Prior exposure to AM103 (no subject may participate in more than one cohort) 2. History or presence of any significant organ system disease, including phenylketonuria, as assessed by medical history, physical examination and laboratory evaluation 3. 12-lead ECG with any abnormality judged by the Investigator to be clinically significant or QTc interval of >450 milliseconds 4. Presence or history of any abnormality or illness, which in the opinion of the Investigator may affect absorption, distribution, metabolism or elimination of the study drug 5. Any screening laboratory evaluation outside the laboratory reference range that is judged by the Investigator to be clinically significant 6. Hemoglobin <7 mmol/L 7. Positive serum test for HIV, hepatitis C or hepatitis B virus infection 8. History of significant allergy to any medication 9. History of alcohol or drug abuse within the past 24 months or positive urine drug screen during screening 10. Use of any tobacco or nicotine containing product within the previous 6 months 11. Administration of any prescription drug within 21 days (oral contraceptives permitted) or over-the-counter drug (paracetamol and ibuprofen =1 g/day permitted) or herbal supplement within 7 days of study drug administration 12. Administration or use of any investigational drug or device within 30 days of study drug administration 13. Blood or plasma donation within 60 days prior to dosing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Adverse events 2. Physical examinations 3. Vital signs 4. ECGs 5. Clinical laboratory values Single Dose Study: Physical examination, vital signs, ECG, and clinical laboratory tests will be carried out on Day 4 (72 ± 4 hours, end-of study time point) after study drug administration. Multiple Dose Study: Vital signs will be assessed at the following timepoints: Day 1: pre-dose, 1, 2, 4, 12, and 24 hours after study drug administration Days 2-10: pre-dose, 2 and 12 hours after study drug administration Day 11: pre-dose, 2, 12 and 24 hours after study drug administration Physical examination, vital signs, ECG, and clinical laboratory tests will be carried out on Day 14 (72 ± 4 hours after the Day 11 dose). ECGs will be carried out at the following timepoints: Single Dose Phase: 2-4 hours after the study drug administration Multiple Dose Phase: 2-4 hours after the first dose of study drug on Day 1 and 2-4 hours after study drug administration on Days 5 and 11. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pharmacokinetics: Concentrations of AM103 in plasma samples will be determined by validated Liquid Chromatography/Mass Spectrometry (LCMS) methods. 2. Pharmacodynamics: Whole blood ionophore-stimulated leukotriene LTB4 and urinary LTE4 production to be assayed by Enzyme Linked Immunosorbent Assay (ELISA) and mass spectrometry, respectively. | — |
Countries
Netherlands
Outcome results
None listed