14473 - D9126C00001 Proof of Principle Study - Effect of AZD2066 on Transient Lower Esophageal Sphincter Relaxations

Reflux Episodes Clinical Trial

Official title:

A Double-blind, Randomized, Placebo-controlled, Single-centre Phase I Pharmacodynamic Cross-over Study to Assess the Effect of a Single Dose of AZD2066 Oral Solution in Comparison to Placebo on Transient Lower Esophageal Sphincter Relaxations (TLESRs) in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00813306
• Other study ID #: D9126C00001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 22, 2008
• Last updated: December 6, 2010
• Start date: December 2008
• Est. completion date: November 2009

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medicines Evaluation Board (MEB)
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to assess the safety and tolerability of AZD2066 and to explore the effect of a single dose of AZD2066 on the function of the cardia (the opening between the stomach and the esophagus) compared to placebo (not containing any medical substance) in healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Provision of written consent prior to any study specific procedures.

• Healthy subjects, age 18-45 years inclusive. Females must be of no childbearing potential or must use a highly effective contraceptive method.

• Clinically normal physical findings and laboratory values at the time of pre-entry visit, as judged by the investigator.

Exclusion Criteria:

• Clinically significant illness within the 2 weeks prior to the first dose of the investigational product, including a suspected/manifested infection according to WHO risk categories 2, 3 or 4, as judged by the investigator.

• A measured LES pressure of < 5mm Hg.

• History of previous or ongoing psychiatric disease/condition.

Study Design

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

Related Conditions & MeSH terms

• Reflux Episodes

Intervention

Drug:
• AZD2066
13 mg oral solution, 1 single dose
• Placebo
Oral solution, 1 single dose
• AZD2066
Dose to be decided after Part A, including dose A (active) and B (placebo). Oral solution, 1 single dose
• AZD2066
Dose to be decided after Part A, including dose A (active) and B (placebo). Oral solution, 1 single dose
• Placebo
Oral solution, 1 single dose

Locations

Country	Name	City	State
Netherlands	Research site	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Manometry		3.45 hours each study period	No
Secondary	pH		3.45 hours each study period	No
Secondary	Impedance		3.45 hours each study period	No
Secondary	Pharmacokinetic variables		3.45 hours each study period	No