Study to Investigate the Pharmacodynamic Effect of a Single Dose of AZD2516 in Healthy Male Subjects

Study Overview
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Brief Summary
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The purpose of this study is to investigate the pharmacodynamic effect of AZD2516 in healthy male subjects.

Detailed Description
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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.

Official Title
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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

Conditions
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Reflux

Intervention / Treatment
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* Drug: AZD2516, 5 mg
* Drug: AZD2516, 16 mg
* Drug: AZD2516, 40 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed informed consent Healthy male subjects Age 18-45 years, inclusive Exclusion Criteria: Clinically significant illness within the 2 weeks prior to the first dose of study drug History of clinically significant cardiovascular, respiratory, renal, hepatic, neurological, mental or gastrointestinal disease Need for concomitant medications during the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: First 5 mg, then placebo, then 16 mg, then 40 mg<br>period 1: AZD2516 5 mg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD2516 16 mg, period 6: washout, period 7: AZD2516 40 mg. | Drug: AZD2516, 5 mg<br>* Capsule, oral<br>Drug: AZD2516, 16 mg<br>* Capsule, oral<br>Drug: AZD2516, 40 mg<br>* Capsule, oral<br>Drug: Placebo<br>* Capsule, oral<br>|
| Experimental: First 40 mg, then 16 mg, then placebo, then 5 mg<br>period 1: AZD2516 40 mg, period 2: washout, period 3: AZD2516 16 mg, period 4: washout, period 5: placebo, period 6: washout, period 7: AZD2516 5 mg. | Drug: AZD2516, 5 mg<br>* Capsule, oral<br>Drug: AZD2516, 16 mg<br>* Capsule, oral<br>Drug: AZD2516, 40 mg<br>* Capsule, oral<br>Drug: Placebo<br>* Capsule, oral<br>|
| Experimental: First 16 mg, then 5 mg, then 40 mg, then placebo<br>period 1: AZD2516 16 mg, period 2: washout, period 3: AZD2516 5 mg, period 4: washout, period 5: AZD2516 40 mg, period 6: washout, period 7: placebo. | Drug: AZD2516, 5 mg<br>* Capsule, oral<br>Drug: AZD2516, 16 mg<br>* Capsule, oral<br>Drug: AZD2516, 40 mg<br>* Capsule, oral<br>Drug: Placebo<br>* Capsule, oral<br>|
| Experimental: First placebo, then 40 mg, then 5 mg, then 16 mg<br>period 1: placebo, period 2: washout, period 3: AZD2516 40 mg, period 4: washout, period 5: AZD2516 5 mg, period 6: washout, period 7: AZD2516 16 mg | Drug: AZD2516, 5 mg<br>* Capsule, oral<br>Drug: AZD2516, 16 mg<br>* Capsule, oral<br>Drug: AZD2516, 40 mg<br>* Capsule, oral<br>Drug: Placebo<br>* Capsule, oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reflux Episodes 0 to 3 Hours Post Meal | Total number of reflux episodes 0 to 3 hours post meal | 0 to 3 hours post meal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transient Lower Esophagus Sphincter Relaxations (TLESRs) 0 to 3 Hours Post Meal | Number of TLESRs 0 to 3 hours post meal were calculated based upon the manometric analysis fpr the 3-hour post-meal period. | 0 to 3 hours post meal | 
| Area Under the Plasma Concentration Curve(AUC) | Area under the plasma concentration vs. time curve from time zero to 12-hours post dose calculated by loglinear trapezoidal method | 0 to 12 hours post dose | 
| Average Plasma Concentration (C Average) | Average plasma concentration | 1 to 4 hours post dose | 
| Maximum Plasma Concentration (Cmax) | Maximum plasma concentration | 0 to 12 hours post dose | 
| Time to Maximum Plasma Concentration (Tmax) | Time to maximum plasma concentration (Tmax) | 0 to 12 hours post dose | 
| Terminal Half-life (T Half) | Terminal half-life (T half) | 0 to 12 hours post dose | 
| Clinically Relevant Change of Laboratory Variables | Number of participants with clinically relevant change of laboratory variables as judged by the responsible medical officer. | Pre-entry to follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacodynamic effect, Reflux inhibition