AZD3355 Dose-escalation Study in Healthy Males

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Reflux Disease

Treatments: Drug: Placebo; Drug: AZD3355

Study type: Interventional

Funder types: Industry

Identifiers

NCT00757419

EudraCTnr: 2008-003578-16

D9120C00030

Details and patient eligibility

About

The aim is to establish the maximal tolerated dose of AZD3355 for the selection of doses in the up-coming studies. This will be done by comparing single and repeated doses of AZD3355 to placebo ("inactive substance"). Safety and tolerability variables will be closely monitored throughout the study.

Enrollment: 54 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects without concurrent diseases who do not require any medical treatments
• Provision of signed informed consent.

Exclusion criteria

• History of somatic disease/condition, which may interfere with the objectives for the study, as judged by the investigator.
• Clinically significant illness or clinically relevant trauma within the 2 weeks prior to the administration of the investigational product, as judged by the investigator.
• History of clinically significant orthostatic reaction or syncope
• Clinically important abnormalities related to the heart function

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: AZD3355

2

Placebo Comparator group

Treatment:

Drug: Placebo