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

AstraZeneca

Status and phase: Completed; Phase 2; Phase 1

Conditions: Reflux Episodes

Treatments: Drug: AZD2066; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00813306

D9126C00001

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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40 participants in 5 patient groups, including a placebo group

A

Experimental group

Description:

AZD2066

Treatment:

Drug: AZD2066

Drug: AZD2066

Drug: AZD2066

B

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Drug: Placebo

C

Experimental group

Description:

AZD2066

Treatment:

Drug: AZD2066

Drug: AZD2066

Drug: AZD2066

D

Experimental group

Description:

AZD2066

Treatment:

Drug: AZD2066

Drug: AZD2066

Drug: AZD2066

E

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Drug: Placebo