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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Reflux

Treatments: Drug: AZD2516, 16 mg; Drug: Placebo; Drug: AZD2516, 5 mg; Drug: AZD2516, 40 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01154634

D3830C00001

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 4 patient groups

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

Experimental group

Description:

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.

Treatment:

Drug: AZD2516, 16 mg

Drug: Placebo

Drug: AZD2516, 40 mg

Drug: AZD2516, 5 mg

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

Experimental group

Description:

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.

Treatment:

Drug: AZD2516, 16 mg

Drug: Placebo

Drug: AZD2516, 40 mg

Drug: AZD2516, 5 mg

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

Experimental group

Description:

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.

Treatment:

Drug: AZD2516, 16 mg

Drug: Placebo

Drug: AZD2516, 40 mg

Drug: AZD2516, 5 mg

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

Experimental group

Description:

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

Treatment:

Drug: AZD2516, 16 mg

Drug: Placebo

Drug: AZD2516, 40 mg

Drug: AZD2516, 5 mg