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

A Single-Centre, Single-Blind, Randomised, Placebo-Controlled, Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Ascending Intravenous Doses of AZD1305 in Healthy Male Japanese Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00738322

Enrollment

Registered

2008-08-20

Start date

2008-07-31

Completion date

2008-10-31

Last updated

2009-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

AZD1305, safety, pharmacokinetics, single ascending doses, Japanese, male

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.

Interventions

DRUGAZD1305

Solution for iv infusion, single dose

DRUGPlacebo

NaCl solution for iv infusion, single dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

20 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Pharmacokinetic variables	During the dosing visits

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026