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: ot Recruiting

Sex: Male

Target Recruitment: 40

Inclusion Criteria

For inclusion in the study subjects should fulfil the following 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.
For inclusion in the genetic research, the study subjects should fulfil the following criterion:
1.Provision of informed consent for optional exploratory genetic research

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Clinically significant illness within the 2 weeks prior to the first dose of the investigational product which may interfere with the objectives of the study, 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 (DSM-IV, APA 1994), as assessed by using the MINI interview (Sheehan et al 1997, Lecrubier et al 1997, Sheehan et al 1998, Amorim et al 1998)
4.Suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) (Posner et al 2007)
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 (OTC) 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
12.Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG obtained at the pre-entry visit, which 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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