heartburn Reflux
Conditions
Interventions
On the testdays (after fasting since midnight) the catheter is inserted via the
nose, after stabilisation the first dose of the study drug is taken (3
capsules), after 45 minutes a second dose of 3
Sponsors
Astra Zeneca
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent prior to any study specific procedures 2. Healthy male subjects, age 18-45 years, inclusive 3.Clinically normal physical findings and laboratory values as judged by the investigator. 4.Body Mass Index (BMI
Exclusion criteria
Exclusion criteria: 1. Clinically significant illness within the 2 weeks prior to the first dose of the investigational product, including a suspected/manifested infection according to WHO risk categories 2, 3 or 4, as judged by the investigator 2. Basal LES pressure of 450 msec or shortened QTcF <350 msec or family history of long QT syndrome 13. Need for concomitant medications during the study (with the exception of OTC nasal spray for relief of nasal congestion and occasional paracetamol for pain relief) 14. Habitual smoker (ie, the subjects smokes every day) or daily use of other nicotine products 15. Blood donation, or similar blood loss, within 12 weeks prior to the first dose of the investigational product 16. Plasma donation within 2 weeks prior to enrolment 17. Positive drug of abuse screen or history of drug addiction and/or alcohol abuse or other circumstances which in the investigators judgment may compromise the subject*s ability to comply with the study requirements 18. Use of anabolic steroids within 12 months prior to the first dose of investigational product 19. Excessive use of caffeine (more than 5 cups of coffee or equivalent per day). 20. Involvement in the planning and conduct of the study 21. Previous randomization or treatment in the present study or previous exposure to AZD2516. For the o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The assessment of the effect of three single doses of AZD2516 on the function of the sphincter between esophagus and stomach, compared to placebo, in healthy volunteers. As primary variable the number of reflux episodes is chosen. | — |
Secondary
| Measure | Time frame |
|---|---|
| Among others the number of relaxations of the lower esophageal sphincter, pharmacokinetics and tolerability of AZD2516. | — |
Countries
Netherlands
Outcome results
None listed