To Study Safety, Tolerability and Pharmacokinetics of AZD1305 in Healthy Male Japanese Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD1305; Drug: Placebo

• Registration Number: NCT00738322
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose is to study the safety of AZD1305, how AZD1305 is tolerated and how the medication is metabolised by the body ( how it is taken up into the body, distributed around the body and disappears from the body) in healthy Japanese males.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-11
• Study First Submitted QC: 2008-08-18
• Study First Posted: 2008-08-20
• Study Completion: 2008-10
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-29
• Last Update Posted: 2009-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

• A body mass index (BMI=weight/height2) of 19 to 27 kg/m2
• Japanese males

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Exclusion Criteria

• ECG findings outside normal reference ranges.
• Potassium outside normal reference ranges.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD1305	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety by assessment of adverse events, ECG variables, BP, pulse rate, physical examination, laboratory variables, body temperature and body weight	During the study

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic variables	During the dosing visits

Trial Locations

Locations (1)

Research Site; 🇯🇵 Fukuoka, Japan