AZD0837 Extended Release (ER) Japan Study (ER J ph I)

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AZD0837; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00904800

D1250C00055

Details and patient eligibility

About

This phase I study will evaluate safety and tolerability after repeated doses of AZD0837.

Enrollment: 36 estimated patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male Japanese subject aged between 20 to 45 years inclusive

Exclusion criteria

• Acute illness (including ongoing or history of liver disease), trauma or surgical procedures within two weeks before Visit 1 or pre first dose in Visit 2
• Intake of another investigational drug within 4 months before Visit 1 or pre first dose in Visit 2
• Blood donation and/or sampling in excess of 200 mL of whole blood within the preceding 4 weeks, 400 mL of whole blood within the preceding 12 weeks and/or 1200 mL of whole blood within the preceding 12 months, before Visit 1 or pre first dose in Visit 2

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

Low dose

Treatment:

Drug: AZD0837

2

Experimental group

Description:

Middle dose

Treatment:

Drug: AZD0837

3

Experimental group

Description:

High dose

Treatment:

Drug: AZD0837

4

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Placebo