NCT01154634

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2010

Shorter than P25 for phase_2

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2010

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
2 years until next milestone

Results Posted

Study results publicly available

August 13, 2012

Completed
Last Updated

August 30, 2012

Status Verified

August 1, 2012

Enrollment Period

4 months

First QC Date

June 15, 2010

Results QC Date

January 27, 2012

Last Update Submit

August 17, 2012

Conditions

Reflux

Keywords

Pharmacodynamic effectReflux inhibition

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

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

    0 to 3 hours post meal

  • Area Under the Plasma Concentration Curve(AUC)

    0 to 12 hours post dose

  • Average Plasma Concentration (C Average)

    1 to 4 hours post dose

  • Maximum Plasma Concentration (Cmax)

    0 to 12 hours post dose

  • Time to Maximum Plasma Concentration (Tmax)

    0 to 12 hours post dose

  • +2 more secondary outcomes

Study Arms (4)

First 5 mg, then placebo, then 16 mg, then 40 mg

EXPERIMENTAL

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 mgDrug: AZD2516, 16 mgDrug: AZD2516, 40 mgDrug: Placebo

First 40 mg, then 16 mg, then placebo, then 5 mg

EXPERIMENTAL

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 mgDrug: AZD2516, 16 mgDrug: AZD2516, 40 mgDrug: Placebo

First 16 mg, then 5 mg, then 40 mg, then placebo

EXPERIMENTAL

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 mgDrug: AZD2516, 16 mgDrug: AZD2516, 40 mgDrug: Placebo

First placebo, then 40 mg, then 5 mg, then 16 mg

EXPERIMENTAL

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 mgDrug: AZD2516, 16 mgDrug: AZD2516, 40 mgDrug: Placebo

Interventions

AZD2516, 5 mgDRUG

Capsule, oral

First 16 mg, then 5 mg, then 40 mg, then placeboFirst 40 mg, then 16 mg, then placebo, then 5 mgFirst 5 mg, then placebo, then 16 mg, then 40 mgFirst placebo, then 40 mg, then 5 mg, then 16 mg
AZD2516, 16 mgDRUG

Capsule, oral

First 16 mg, then 5 mg, then 40 mg, then placeboFirst 40 mg, then 16 mg, then placebo, then 5 mgFirst 5 mg, then placebo, then 16 mg, then 40 mgFirst placebo, then 40 mg, then 5 mg, then 16 mg
AZD2516, 40 mgDRUG

Capsule, oral

First 16 mg, then 5 mg, then 40 mg, then placeboFirst 40 mg, then 16 mg, then placebo, then 5 mgFirst 5 mg, then placebo, then 16 mg, then 40 mgFirst placebo, then 40 mg, then 5 mg, then 16 mg
PlaceboDRUG

Capsule, oral

First 16 mg, then 5 mg, then 40 mg, then placeboFirst 40 mg, then 16 mg, then placebo, then 5 mgFirst 5 mg, then placebo, then 16 mg, then 40 mgFirst placebo, then 40 mg, then 5 mg, then 16 mg

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Provision of signed informed consent
  • Healthy male subjects
  • Age 18-45 years, inclusive

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Leuven, Belgium

Location

Research Site

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com
+44 1625 518062

Study Officials

  • Mark Berner Hansen

    AstraZeneca R&D Molndal

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2010

First Posted

July 1, 2010

Study Start

May 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

August 30, 2012

Results First Posted

August 13, 2012

Record last verified: 2012-08

Locations

BE(1)NL(1)