Study to Investigate the Activity of AZD5122 When Given as a Single Dose to Healthy Male Subjects

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AZD5122; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00984477

D2650C00006

Details and patient eligibility

About

The purpose of the study is to determine how quickly AZD5122 is absorbed into and cleared by the body when given to healthy, non smoking males at different dose levels. This is a 2 part study, in Part B a single group of subjects will be given both an oral dose and intravenous microdose of AZD5122 at a specialist unit. For part B there is no placebo treatment given.

Enrollment: 100 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of signed and dated, written informed consent.
• Normal physical examination, laboratory values, blood pressure and pulse
• Healthy male caucasian subjects

Exclusion criteria

• Subjects must not have any history of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with how drugs are absorbed, used or eliminated by the body.
• Subjects must not have abnormal blood or urine tests for hsCRP, circulating neutrophils, haematocrit, haemoglobin or renal function
• Subjects must not have crystals or more than a trace of blood in their urine

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

AZD5122 oral suspension (part A and B)

Treatment:

Drug: AZD5122

Drug: AZD5122

2

Placebo Comparator group

Description:

Placebo oral suspension (part A)

Treatment:

Drug: Placebo

3

Experimental group

Description:

AZD5122 oral and IV infusion (part B)

Treatment:

Drug: AZD5122

Drug: AZD5122