A First Time in Man, Study to Assess the Safety of AZD8329 After Single Ascending Oral Doses

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Men

Treatments: Drug: AZD8329; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00935662

EudraCT No. 2009-010702-11

D2350C00001

Details and patient eligibility

About

The primary objective for this study is to assess the safety and tolerability of AZD8329 when given as a single dose in increasing dose strength, and also to identify the highest tolerated dose for future studies.

Enrollment: 119 estimated patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of informed consent prior to any study specific procedures
• Have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg

Exclusion criteria

• Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject´s ability to participate
• Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
• Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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119 participants in 2 patient groups, including a placebo group

AZD8329

Experimental group

Description:

AZD8329 oral solution

Treatment:

Drug: AZD8329

Placebo

Placebo Comparator group

Description:

Placebo for AZD8329 oral solution

Treatment:

Drug: Placebo