AZD8683 Single Ascending Dose Study

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: AZD8683

Study type: Interventional

Funder types: Industry

Identifiers

NCT00979849

D1883C00001

Details and patient eligibility

About

The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD8683 following single ascending dose administrations in healthy male subjects.

Enrollment: 130 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of signed, written and dated informed consent prior to any study specific procedures
• Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
• Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to study start

Exclusion criteria

• Any clinically significant disease or disorder
• Any clinically significant abnormalities at screening examinations
• Use any prescribed or non-prescribed medication

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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130 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

AZD8683

Treatment:

Drug: AZD8683

B

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo