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

Reflux Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01154634
• Other study ID #: D3830C00001
• Status: Completed
• Phase: Phase 2
• First received: June 15, 2010
• Last updated: August 17, 2012
• Start date: May 2010
• Est. completion date: September 2010

Study information

• Verified date: August 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Reflux

Intervention

Drug:
• AZD2516, 5 mg
Capsule, oral
• AZD2516, 16 mg
Capsule, oral
• AZD2516, 40 mg
Capsule, oral
• Placebo
Capsule, oral

Locations

Country	Name	City	State
Belgium	Research Site	Leuven
Netherlands	Research Site	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Average Plasma Concentration (C Average)	Average plasma concentration	1 to 4 hours post dose	No
Secondary	Maximum Plasma Concentration (Cmax)	Maximum plasma concentration	0 to 12 hours post dose	No
Secondary	Time to Maximum Plasma Concentration (Tmax)	Time to maximum plasma concentration (Tmax)	0 to 12 hours post dose	No
Secondary	Terminal Half-life (T Half)	Terminal half-life (T half)	0 to 12 hours post dose	No
Secondary	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	Yes