Additional identifiers
EudraCT number
2007-002229-59
ClinicalTrials.gov number
Protocol/serial number
The Sponsor (Amira) code: CL-AM103-01; PRA International (a contract research organization) code: AMA70921-070921
Study information
Scientific title
Acronym
Study hypothesis
To assess the following:
Primary:
Safety and tolerability of single and multiple doses of AM103 following oral administration.
Secondary:
1. Pharmacokinetics (PK) of AM103 after single and multiple doses.
2. Effects of AM103 on Pharmacodynamic (PD) markers: whole blood ionophore-stimulated leukotriene LTB4 and urinary LTE4 production.
Ethics approval
Medical Ethical Review Committee (METC) of the BEBO foundation (Ethics Review / Bio-medical Research) (METC van de stichting BEBO) Postbus 1004, 9400 BA Assen, and Noorderstaete 20, 9402 XB Assen, the Netherlands. Approved on 22nd May 2007.
Study design
Single-center, double-blind, randomized, placebo-controlled, single dose followed by multiple dose study.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Healthy volunteers. Study is primarily relevant in asthma and allergic rhinitis.
Intervention
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 additional group to be defined (after the prior doses have concluded).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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 outcome measures
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.
Overall trial start date
18/06/2007
Overall trial end date
31/10/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Up to 72 (40 in single dose phase; 32 in multiple dose phase)
Participant 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
Recruitment start date
18/06/2007
Recruitment end date
31/10/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Stationsweg 163
9470 AE Zuidlaren
9470 AE
Netherlands
Sponsor information
Organisation
Amira Pharmaceuticals (USA)
Sponsor details
c/o Dr Mark Moran
9535 Waples Street
Ste. 100
San Diego
92121
United States of America
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Amira Pharmaceuticals (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list