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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01154634
First received: June 15, 2010
Last updated: August 17, 2012
Last verified: August 2012
  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:


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 April 16, 2014