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

AstraZeneca20 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Reflux

Interventions

AZD2516, 5 mgDRUG

Capsule, oral

AZD2516, 16 mgDRUG

Capsule, oral

AZD2516, 40 mgDRUG

Capsule, oral

Placebo

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Research Site

Leuven, Belgium

Research Site

Amsterdam, Netherlands

Outcomes

Primary Outcomes

Reflux Episodes 0 to 3 Hours Post Meal

Total number of reflux episodes 0 to 3 hours post meal

Time frame: 0 to 3 hours post meal

Secondary Outcomes

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.

Time frame: 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

Time frame: 0 to 12 hours post dose

Average Plasma Concentration (C Average)

Average plasma concentration

Time frame: 1 to 4 hours post dose

Maximum Plasma Concentration (Cmax)

Maximum plasma concentration

Time frame: 0 to 12 hours post dose

Time to Maximum Plasma Concentration (Tmax)

Time to maximum plasma concentration (Tmax)

Time frame: 0 to 12 hours post dose

Terminal Half-life (T Half)

Terminal half-life (T half)

Time frame: 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.

Data from ClinicalTrials.gov

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