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

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ClinicalTrials.gov Identifier: NCT01154634
Recruitment Status : Completed
First Posted : July 1, 2010
Results First Posted : August 13, 2012
Last Update Posted : August 30, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Reflux Drug: AZD2516, 5 mg Drug: AZD2516, 16 mg Drug: AZD2516, 40 mg Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : May 2010
Primary Completion Date : September 2010
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01154634     History of Changes
Other Study ID Numbers: D3830C00001
First Posted: July 1, 2010    Key Record Dates
Results First Posted: August 13, 2012
Last Update Posted: August 30, 2012
Last Verified: August 2012

Keywords provided by AstraZeneca:
Pharmacodynamic effect
Reflux inhibition