Study to Investigate the Pharmacodynamic Effect of a Single Dose 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

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

Study Overview

• Status: Completed
• Conditions: Reflux
• Intervention / Treatment: Drug: AZD2516, 5 mg; Drug: AZD2516, 16 mg; Drug: AZD2516, 40 mg; Drug: Placebo

Detailed Description

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
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium
    • Research Site
• Netherlands
  • Amsterdam, Netherlands
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: First 5 mg, then placebo, then 16 mg, then 40 mg; 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; Capsule, oral; Drug: AZD2516, 16 mg; Capsule, oral; Drug: AZD2516, 40 mg; Capsule, oral; Drug: Placebo; Capsule, oral
Experimental: First 40 mg, then 16 mg, then placebo, then 5 mg; 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; Capsule, oral; Drug: AZD2516, 16 mg; Capsule, oral; Drug: AZD2516, 40 mg; Capsule, oral; Drug: Placebo; Capsule, oral
Experimental: First 16 mg, then 5 mg, then 40 mg, then placebo; 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; Capsule, oral; Drug: AZD2516, 16 mg; Capsule, oral; Drug: AZD2516, 40 mg; Capsule, oral; Drug: Placebo; Capsule, oral
Experimental: First placebo, then 40 mg, then 5 mg, then 16 mg; 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; Capsule, oral; Drug: AZD2516, 16 mg; Capsule, oral; Drug: AZD2516, 40 mg; Capsule, oral; Drug: Placebo; Capsule, oral

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Mark Berner Hansen, AstraZeneca R&D Mölndal

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: June 15, 2010
• First Submitted That Met QC Criteria: June 29, 2010
• First Posted (Estimate): July 1, 2010

Study Record Updates

• Last Update Posted (Estimate): August 30, 2012
• Last Update Submitted That Met QC Criteria: August 17, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Pharmacodynamic effect; Reflux inhibition
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: D3830C00001