Gastroesophageal Reflux Disease (GERD) MedDRA version: 12.1 Level: LLT Classification code 10017924 Term: Gastroesophageal reflux
Conditions
Interventions
Product Code: AZD2516
Pharmaceutical Form: Capsule, hard
Current Sponsor code: AZD2516
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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 450 msec or shortened QTcF <350 msec or family history of long QT syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary study objective is to assess the effect of AZD2516, measured as reduction in the total number of reflux episodes during a 3-hour post meal period compared to placebo.;Secondary Objective: • To assess the effect of AZD2516, measured as reduction in the number of transient lower esophageal sphincter relaxations (TLESRs) during a 3-hour post meal period compared to placebo. • To assess the number of acid-, weakly acidic- and weakly alkaline reflux episodes during a 3-hour post meal period • To assess the height (mean proximal extent) and content (liquid, gas or a mixture) of the refluxate • To assess the time with esophageal pH between 4 and 6.5 during a 3-hour post meal period • To assess the time with esophageal pH<4 during a 3-hour post meal period • To assess the lower esophageal sphincter (LES) pressure during a 3-hour post meal period • To assess the number of concurrent TLESRs and acid- and weakly-or non acid reflux episodes during a 3-hour post meal period • To assess the effect of AZD2516 on the number of swallows during a 3-hour post meal period • To assess the pharmacokinetic profile of AZD2516 • To assess the safety and tolerability of AZD2516. ;Primary end point(s): Pharmacodynamic - Number of reflux episodes including start and end time of each event - Reflux episodes pH category (Acid [pH<4], Weakly acidic [4=pH<6.5], Weakly alkaline [pH=6.5]) - Content of reflux episodes (Liquid, Gas, Mixed) - Bolus clearance time - Fraction of time with esophageal pH between 4 and 6.5 - Fraction of time with esophageal pH<4 - Number of TLESRs including start and end time of event - Concurrence of reflux episodes and TLESRs - LES pressure - Number of swallows Pharmacokinetic - AUC(0-t) - AUC(1-4 h) - Caverage (1-4 h) - Cmax - tmax - t1/2 Safety - Adverse Events (AEs), - Blood pressure (BP) - Pulse - Laboratory variables - Columbia Suicidality Severity Rating Scale (C-SSRS) | — |
Countries
Belgium
Outcome results
None listed