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Completed

NCT Number: NCT01154634

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

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

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Key information

Conditions

Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Leuven, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD2516, 5 mg

Drug

Capsule, oral

AZD2516, 16 mg

Drug

Capsule, oral

AZD2516, 40 mg

Drug

Capsule, oral

Placebo

Drug

Capsule, oral

Primary outcomes

  1. Reflux Episodes 0 to 3 Hours Post Meal

    Time frame: 0 to 3 hours post meal

    Total number of reflux episodes 0 to 3 hours post meal

Secondary outcomes

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

    Time frame: 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.

  2. Area Under the Plasma Concentration Curve(AUC)

    Time frame: 0 to 12 hours post dose

    Area under the plasma concentration vs. time curve from time zero to 12-hours post dose calculated by loglinear trapezoidal method

  3. Average Plasma Concentration (C Average)

    Time frame: 1 to 4 hours post dose

    Average plasma concentration

  4. Maximum Plasma Concentration (Cmax)

    Time frame: 0 to 12 hours post dose

    Maximum plasma concentration

  5. Time to Maximum Plasma Concentration (Tmax)

    Time frame: 0 to 12 hours post dose

    Time to maximum plasma concentration (Tmax)

  6. Terminal Half-life (T Half)

    Time frame: 0 to 12 hours post dose

    Terminal half-life (T half)

  7. Clinically Relevant Change of Laboratory Variables

    Time frame: Pre-entry to follow-up

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jul 1, 2010
Registry last updated
Aug 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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