A double-blind, randomized, placebo-controlled, two-centre, phase IIa pharmacodynamic cross-over study to assess the effect of AZD2516 on the total number of reflux episodes in healthy male volunteers

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 20

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<=weight/height2) 19-30 kg/m2 calculated from height and weight given in the demographic data.

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 < 5 mmHg
3. History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder according to the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, as assessed by using the MINI psychiatric interview.
4. Suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale in the last month
5. History of psychotic disorder among first-degree relatives
6. History of use of antipsychotic, antidepressant or anxiolytic drugs, prescribed as well as non-prescribed use. History of antidepressants or anxiolytics for non-psychiatric conditions such as pain or postoperative insomnia is allowed
7. History of clinically significant cardiovascular, respiratory, renal, hepatic, neurological, mental or gastrointestinal disease, as judged by the investigator
8. Use of prescribed medication and over-the-counter drugs (including herbal remedies minerals and vitamins) during 2 weeks before administration of investigational product. However, paracetamol may be taken occasionally for pain relief as well as OTC adrenergic nasal spray for relief of nasal congestion
9. Administration of any investigational product within 8 weeks prior to the first dose of AZD2516
10. Any condition that could modify the absorption of the drug, as judged by the investigator
11. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity
12. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG obtained at the pre-entry visit, that may interfere with the interpretation of QTc interval changes. This includes subjects with any of the following: Clinically significant PR (PQ) interval prolongation, Intermittent second or third degree AV block, Incomplete, full or intermittent bundle branch block (QRS<120 msec with normal QRS and T wave morphology is acceptable if there is no evidence of left ventricular hypertrophy), Abnormal T wave morphology, particularly in the protocol defined primary lead (lead V2), Prolonged QTcF >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.
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Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The assessment of the effect of three single doses of AZD2516 on the function<br /><br>of the sphincter between esophagus and stomach, compared to placebo, in healthy<br /><br>volunteers. As primary variable the number of reflux episodes is chosen.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Among others the number of relaxations of the lower esophageal sphincter,<br /><br>pharmacokinetics and tolerability of AZD2516.</p><br>

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