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

Primary Purpose

Reflux

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

AZD2516, 5 mg

AZD2516, 16 mg

AZD2516, 40 mg

Placebo

About this trial

This is an interventional basic science trial for Reflux focused on measuring Pharmacodynamic effect, Reflux inhibition

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Research Site
Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

First 5 mg, then placebo, then 16 mg, then 40 mg

First 40 mg, then 16 mg, then placebo, then 5 mg

First 16 mg, then 5 mg, then 40 mg, then placebo

First placebo, then 40 mg, then 5 mg, then 16 mg

Arm Description

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.

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.

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.

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

Outcomes

Primary Outcome Measures

Reflux Episodes 0 to 3 Hours Post Meal

Total number of reflux episodes 0 to 3 hours post meal

Secondary Outcome Measures

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.

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

Average Plasma Concentration (C Average)

Average plasma concentration

Maximum Plasma Concentration (Cmax)

Maximum plasma concentration

Time to Maximum Plasma Concentration (Tmax)

Time to maximum plasma concentration (Tmax)

Terminal Half-life (T Half)

Terminal half-life (T half)

Clinically Relevant Change of Laboratory Variables

Number of participants with clinically relevant change of laboratory variables as judged by the responsible medical officer.

Full Information

NCT ID

NCT01154634

First Posted

June 15, 2010

Last Updated

August 17, 2012

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01154634

Brief Title

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

Official Title

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

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

May 2010 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Reflux

Keywords

Pharmacodynamic effect, Reflux inhibition

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

First 5 mg, then placebo, then 16 mg, then 40 mg

Arm Type

Experimental

Arm Description

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.

Arm Title

First 40 mg, then 16 mg, then placebo, then 5 mg

Arm Type

Experimental

Arm Description

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.

Arm Title

First 16 mg, then 5 mg, then 40 mg, then placebo

Arm Type

Experimental

Arm Description

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.

Arm Title

First placebo, then 40 mg, then 5 mg, then 16 mg

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

AZD2516, 5 mg

Intervention Description

Capsule, oral

Intervention Type

Drug

Intervention Name(s)

AZD2516, 16 mg

Intervention Description

Capsule, oral

Intervention Type

Drug

Intervention Name(s)

AZD2516, 40 mg

Intervention Description

Capsule, oral

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Capsule, oral

Primary Outcome Measure Information:

Title

Reflux Episodes 0 to 3 Hours Post Meal

Description

Total number of reflux episodes 0 to 3 hours post meal

Time Frame

0 to 3 hours post meal

Secondary Outcome Measure Information:

Title

Transient Lower Esophagus Sphincter Relaxations (TLESRs) 0 to 3 Hours Post Meal

Description

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

Title

Area Under the Plasma Concentration Curve(AUC)

Description

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

Title

Average Plasma Concentration (C Average)

Description

Average plasma concentration

Time Frame

1 to 4 hours post dose

Title

Maximum Plasma Concentration (Cmax)

Description

Maximum plasma concentration

Time Frame

0 to 12 hours post dose

Title

Time to Maximum Plasma Concentration (Tmax)

Description

Time to maximum plasma concentration (Tmax)

Time Frame

0 to 12 hours post dose

Title

Terminal Half-life (T Half)

Description

Terminal half-life (T half)

Time Frame

0 to 12 hours post dose

Title

Clinically Relevant Change of Laboratory Variables

Description

Number of participants with clinically relevant change of laboratory variables as judged by the responsible medical officer.

Time Frame

Pre-entry to follow-up

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Berner Hansen

Organizational Affiliation

AstraZeneca R&D Molndal

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Leuven

Country

Belgium

Facility Name

Research Site

City

Amsterdam

Country

Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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