AZD0837 Extended Release (ER) Japan Study

Phase 1CompletedNCT00904800

AstraZeneca36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Healthy

Interventions

AZD0837DRUG

tablet, oral, once daily, 1+5 days

PlaceboDRUG

Placebo

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Kagoshima, Japan

Outcomes

Primary Outcomes

To investigate the safety and tolerability of AZD0837 after single and repeated oral dosing of AZD0837 extended release (ER) tablet, in Japanese healthy subjects.

Time frame: All assessments are made at each visit, at least daily, during the study.

Secondary Outcomes

To investigate the pharmacokinetics (PK) of AZD0837, AR H069927XX and AR-H067637XX after single and repeated oral dosing of AZD0837 ER tablet, in Japanese healthy subjects.

Time frame: Blood samples will be taken before and after study drug administration.

Data from ClinicalTrials.gov

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