Study to Investigate the Pharmacodynamic Effect of a Single Dose of AZD2516 in Healthy Male Subjects - Full Text View

Purpose

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

Condition	Intervention	Phase
Reflux	Drug: AZD2516, 5 mg Drug: AZD2516, 16 mg Drug: AZD2516, 40 mg Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Basic Science
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

Resource links provided by NLM:

MedlinePlus related topics: GERD

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Reflux Episodes 0 to 3 Hours Post Meal [ Time Frame: 0 to 3 hours post meal ] [ Designated as safety issue: No ]
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 [ Time Frame: 0 to 3 hours post meal ] [ Designated as safety issue: No ]
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) [ Time Frame: 0 to 12 hours post dose ] [ Designated as safety issue: No ]
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) [ Time Frame: 1 to 4 hours post dose ] [ Designated as safety issue: No ]
Average plasma concentration
Maximum Plasma Concentration (Cmax) [ Time Frame: 0 to 12 hours post dose ] [ Designated as safety issue: No ]
Maximum plasma concentration
Time to Maximum Plasma Concentration (Tmax) [ Time Frame: 0 to 12 hours post dose ] [ Designated as safety issue: No ]
Time to maximum plasma concentration (Tmax)
Terminal Half-life (T Half) [ Time Frame: 0 to 12 hours post dose ] [ Designated as safety issue: No ]
Terminal half-life (T half)
Clinically Relevant Change of Laboratory Variables [ Time Frame: Pre-entry to follow-up ] [ Designated as safety issue: Yes ]
Number of participants with clinically relevant change of laboratory variables as judged by the responsible medical officer.

Enrollment:	20
Study Start Date:	May 2010
Study Completion Date:	September 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01154634

Locations

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

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Mark Berner Hansen

AstraZeneca R&D Molndal

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01154634 History of Changes
Other Study ID Numbers:	D3830C00001
Study First Received:	June 15, 2010
Results First Received:	January 27, 2012
Last Updated:	August 17, 2012
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by AstraZeneca:

Pharmacodynamic effect
Reflux inhibition

Additional relevant MeSH terms:

Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders

Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 22, 2013